Latest FDA drug recalls

September 2026

1. September 11, 2026 · Class II · Ongoing · D-0002-2027

   Lack of Assurance of Sterility

   Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47 — K.C. Pharmaceuticals, Inc.

2. September 10, 2026 · Class II · Ongoing · D-0032-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 — Carolina Infusion, LLC

3. September 10, 2026 · Class II · Ongoing · D-0031-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29 — Carolina Infusion, LLC

4. September 10, 2026 · Class II · Ongoing · D-0030-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   TIRZEPATIDE/CYANOCOBALAMIN 85/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299 — Carolina Infusion, LLC

5. September 10, 2026 · Class II · Ongoing · D-0029-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299 — Carolina Infusion, LLC

6. September 10, 2026 · Class II · Ongoing · D-0028-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   TIRZEPATIDE/CYANOCOBALAMIN 64/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299 — Carolina Infusion, LLC

7. September 10, 2026 · Class II · Ongoing · D-0027-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   TIRZEPATIDE/CYANOCOBALAMIN 26/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 299 — Carolina Infusion, LLC

8. September 10, 2026 · Class II · Ongoing · D-0026-2027

   Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

   SEMAGLUTIDE/CYANOCOBALAMIN 9/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993 — Carolina Infusion, LLC

9. September 10, 2026 · Class II · Ongoing · D-0025-2027

   Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

   Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29 — Carolina Infusion, LLC

10. September 10, 2026 · Class II · Ongoing · D-0024-2027

    Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

    Tri-MIX (PAPAV/PHENTO/ALPROS), 30/1/40, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2 — Carolina Infusion, LLC

11. September 10, 2026 · Class II · Ongoing · D-0023-2027

    Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

    Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29 — Carolina Infusion, LLC

12. September 10, 2026 · Class II · Ongoing · D-0022-2027

    Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

    Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/20, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29 — Carolina Infusion, LLC

13. September 10, 2026 · Class II · Ongoing · D-0021-2027

    Lack of Assurance of Sterility: Related to processing equipment used in compounded product.

    QUAD-MIX( PAPAV/PHENTO/ALPROS/TROP) INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 — Carolina Infusion, LLC

14. September 10, 2026 · Class II · Ongoing · D-0020-2027

    Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    SERMORELIN ACETATE 1 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland — Carolina Infusion, LLC

15. September 10, 2026 · Class II · Ongoing · D-0019-2027

    Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    SEMAGLUTIDE/CYANOCOBALAMIN 3/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 2993 — Carolina Infusion, LLC

16. September 10, 2026 · Class II · Ongoing · D-0018-2027

    Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    SEMAGLUTIDE 3 MG/ML INJECTABLE, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936 — Carolina Infusion, LLC

17. September 10, 2026 · Class II · Ongoing · D-0017-2027

    Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.

    TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936; — Carolina Infusion, LLC

18. September 8, 2026 · Class II · Ongoing · D-0876-2026

    Crystallization

    Buprenorphine Hydrochloride, Injection 0.3 mg/mL, Rx Only, 5 x 1 mL Single Dose Vials, Manufactured for: Endo USA, Malvern, PA, NDC 42023-179-05 — Par Health USA, LLC

    Medicine pages: Buprenorphine

19. September 8, 2026 · Class II · Ongoing · D-0873-2026

    Defective Container; packets were found to be either empty or partially full.

    Estradiol Gel, 0.1%, 0.25 mg, 30-packets per carton, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08907, NDC 69238-2452-3. — Amneal Pharmaceuticals, LLC

    Medicine pages: Estradiol

20. September 4, 2026 · Class II · Ongoing · D-0853-2026

    Lack of Assurance of Sterility

    Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL), 5 mL Single-dose, 25 vials per tray, Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, Vial NDC 0409-5820-11, Carton NDC 0409-5820-01. — Pfizer

    Medicine pages: Dopamine hydrochloride

21. September 3, 2026 · Class II · Ongoing · D-0864-2026

    Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

    fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01. — OurPharma LLC

22. September 3, 2026 · Class II · Ongoing · D-0852-2026

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Manufactured by: Inventia Healthcare Limited. NDC: 64980-599-01 — Inventia Healthcare Limited

    Medicine pages: Chlorthalidone

23. September 1, 2026 · Class II · Ongoing · D-0879-2026

    Microbial contamination of topical product.

    Benzoyl Peroxide Wash, USP, 10%, packaged in a)5 FL OZ (148mL) bottles (NDC 0536-1261-63), and b) 8.5 FL OZ (237 mL) bottles (NDC 0536-1351-42), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, — SV Labs Toronto Corporation

24. September 1, 2026 · Class II · Ongoing · D-0878-2026

    Microbial contamination of topical product.

    Benzoyl Peroxide Wash, USP, 5%, 5 FL OZ (148 mL), Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1259-63 — SV Labs Toronto Corporation

August 2026

1. August 31, 2026 · Class II · Ongoing · D-0875-2026

   Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours.

   Zoladex (goserelin) implant, 3.6 mg, One single-Use Syringe packaged in a carton, Rx only, Manufactured for: TerSera therapeutics LLC, Deerfield, IL 60015, BY: AstraZeneca UK Limited, Macclesfield, England, Product of Sw — TerSera Therapeutics LLC

   Medicine pages: Goserelin

2. August 31, 2026 · Class II · Ongoing · D-0848-2026

   Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

   Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5 — SUN PHARMA /TARO

   Medicine pages: Lidocaine

3. August 31, 2026 · Class III · Ongoing · D-0833-2026

   Failed dissolution specifications.

   Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 2085 — Supernus Pharmaceuticals, Inc.

   Medicine pages: Topiramate

4. August 28, 2026 · Class II · Ongoing · D-0868-2026

   Defective Delivery System: Possibility of no medication in the prefilled pen.

   Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amn — Amneal Pharmaceuticals of New York, LLC

   Medicine pages: Exenatide

5. August 27, 2026 · Class III · Ongoing · D-0867-2026

   Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

   Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07. — Macleods Pharmaceuticals Limited

   Medicine pages: Olanzapine

6. August 26, 2026 · Class II · Ongoing · D-0830-2026

   Failed Dissolution Specifications

   Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: My — Mylan Pharmaceuticals Inc

   Medicine pages: Mycophenolate mofetil

7. August 25, 2026 · Class III · Ongoing · D-0836-2026

   Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.

   Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. — Ajanta Pharma USA Inc

   Medicine pages: Fluphenazine hydrochloride

8. August 24, 2026 · Class III · Ongoing · D-0835-2026

   Subpotent Drug

   Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10 — ImprimisRx NJ LLC

9. August 24, 2026 · Class II · Ongoing · D-0834-2026

   Presence of Foreign Tablets/Capsules

   traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01 — Teva Pharmaceuticals USA, Inc

   Medicine pages: Trazodone hydrochloride

10. August 24, 2026 · Class II · Ongoing · D-0831-2026

    Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).

    Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: — Hikma Pharmaceuticals USA INC.

    Medicine pages: Ramipril

11. August 21, 2026 · Class I · Ongoing · D-0866-2026

    Superpotent Drug

    Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg, liothyronine (T3) 4.5 mcg, 100 Tablets, Rx only, Distributed by: Vitruvias Therapeutics, Auburn, AL 36830, Product of USA, NDC 696 — VITRUVIAS THERAPEUTICS INC

12. August 21, 2026 · Class II · Ongoing · D-0847-2026

    Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution

    Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30. — Golden State Medical Supply Inc.

    Medicine pages: Prasugrel

13. August 21, 2026 · Class II · Ongoing · D-0829-2026

    CGMP Deviations: Potential contamination of raw material

    Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4 — Lexia LLC

14. August 21, 2026 · Class II · Ongoing · D-0828-2026

    CGMP Deviations: Potential contamination of raw material

    Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7 — Lexia LLC

15. August 20, 2026 · Class II · Ongoing · D-0863-2026

    Lack of Assurance of Sterility

    AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-0 — Sterling Pharmaceutical Services LLC

16. August 20, 2026 · Class II · Ongoing · D-0862-2026

    Lack of Assurance of Sterility

    Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05 — Sterling Pharmaceutical Services LLC

17. August 20, 2026 · Class II · Ongoing · D-0861-2026

    Lack of Assurance of Sterility

    Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38 — Sterling Pharmaceutical Services LLC

18. August 20, 2026 · Class II · Ongoing · D-0860-2026

    Lack of Assurance of Sterility

    TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, — Sterling Pharmaceutical Services LLC

19. August 20, 2026 · Class II · Ongoing · D-0859-2026

    Lack of Assurance of Sterility

    Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55. — Sterling Pharmaceutical Services LLC

20. August 20, 2026 · Class II · Ongoing · D-0858-2026

    Lack of Assurance of Sterility

    Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15. — Sterling Pharmaceutical Services LLC

21. August 20, 2026 · Class II · Ongoing · D-0857-2026

    Lack of Assurance of Sterility

    Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15. — Sterling Pharmaceutical Services LLC

22. August 20, 2026 · Class II · Ongoing · D-0856-2026

    Lack of Assurance of Sterility

    Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55. — Sterling Pharmaceutical Services LLC

23. August 20, 2026 · Class II · Ongoing · D-0855-2026

    Lack of Assurance of Sterility

    AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15 — Sterling Pharmaceutical Services LLC

24. August 19, 2026 · Class I · Ongoing · D-0869-2026

    Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene

    0.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018 USA, NDC 0264-1800-32. — B BRAUN MEDICAL INC

    Medicine pages: Sodium chloride

25. August 19, 2026 · Class III · Ongoing · D-0840-2026

    Labeling: Label Mix-up

    Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11). — American Health Packaging

    Medicine pages: Buprenorphine

26. August 19, 2026 · Class III · Ongoing · D-0838-2026

    Failed Stability Specifications: Out of specification stability result for the protein concentration profile.

    Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01 — Chiesi USA, Inc.

    Medicine pages: Elapegademase-lvlr

27. August 18, 2026 · Class II · Ongoing · D-0837-2026

    Cross Contamination with Other Products

    2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26 — Sage Products, LLC

28. August 17, 2026 · Class I · Ongoing · D-0850-2026

    Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.

    Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06 — Baxter Healthcare Corporation

29. August 17, 2026 · Class I · Ongoing · D-0849-2026

    Presence of particulate matter: Particulates identified as fiberglass

    0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03 — Baxter Healthcare Corporation

    Medicine pages: Sodium chloride

30. August 17, 2026 · Class II · Ongoing · D-0839-2026

    Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria

    Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93. — Mylan Pharmaceuticals Inc

    Medicine pages: Prasugrel

31. August 14, 2026 · Class II · Ongoing · D-0826-2026

    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853 — Allies Group Inc.

32. August 14, 2026 · Class II · Ongoing · D-0825-2026

    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 0747 — Allies Group Inc.

33. August 14, 2026 · Class II · Ongoing · D-0824-2026

    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. — Allies Group Inc.

34. August 14, 2026 · Class II · Ongoing · D-0823-2026

    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.

    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224 — Allies Group Inc.

35. August 13, 2026 · Class II · Ongoing · D-0846-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 20 mg per 4 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Safecor Health, LLC

36. August 13, 2026 · Class II · Ongoing · D-0845-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 15 mg per 3 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Safecor Health, LLC

37. August 13, 2026 · Class II · Ongoing · D-0844-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Safecor Health, LLC

38. August 13, 2026 · Class II · Ongoing · D-0843-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 5 mg per 10 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 — Safecor Health, LLC

39. August 13, 2026 · Class II · Ongoing · D-0842-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0653-04 — Safecor Health, LLC

40. August 13, 2026 · Class II · Ongoing · D-0841-2026

    Failed Stability Specifications

    Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol 14% by volume, For Oral Use Only, Rx Only, Pkg by: Safecor Health, Woburn, MA 01801. NDC: 00121-0654-16 — Safecor Health, LLC

41. August 13, 2026 · Class II · Ongoing · D-0804-2026

    Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria

    Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 — Apotex Corp.

    Medicine pages: Paroxetine

42. August 12, 2026 · Class I · Ongoing · D-0832-2026

    Presence of Particulate matter.

    Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00 — B BRAUN MEDICAL INC

    Medicine pages: Sodium chloride, sodium lactate, potassium chloride, and calcium chloride

43. August 11, 2026 · Class I · Ongoing · D-0865-2026

    Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and leaking vials.

    Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For Intravenous Infusion, intramuscular and Subcutaneous Use, AMERICAN REGENT INC., SHIRLEY, NY 11967. NDC 0517-3030-01 — American Regent, Inc.

    Medicine pages: Epinephrine

44. August 10, 2026 · Class I · Ongoing · D-0827-2026

    Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.

    Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20. — Fresenius Kabi USA, LLC

    Medicine pages: Tocilizumab

45. August 10, 2026 · Class II · Ongoing · D-0790-2026

    CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing

    Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205. — Church & Dwight Co., Inc.

46. August 8, 2026 · Class II · Ongoing · D-0854-2026

    cGMP Deviations

    MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content, 9g/0.32 oz, Manufactured by: Shantzu Qiwei Industry Co. Ltd, Add: Quiwei Building, Yingloinguan, Xiashan, Chaonan district, Shantou City, Guangdong Province, China — SHANTOU Qiwei industrial Co., Ltd

47. August 7, 2026 · Class III · Ongoing · D-0822-2026

    Presence of Foreign Tablets/Capsules

    Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20. — Bionpharma Inc.

    Medicine pages: Doxylamine succinate and pyridoxine hydrochloride

48. August 7, 2026 · Class II · Ongoing · D-0771-2026

    CGMP deviations: tablets with black specks.

    Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorpora — Golden State Medical Supply Inc.

    Medicine pages: Carbamazepine

49. August 6, 2026 · Class II · Ongoing · D-0821-2026

    CGMP Deviations

    Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC — Baxter Healthcare Corporation

    Medicine pages: Daptomycin

50. August 6, 2026 · Class II · Ongoing · D-0820-2026

    CGMP Deviations

    Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01. — Baxter Healthcare Corporation

    Medicine pages: Vancomycin

51. August 6, 2026 · Class II · Ongoing · D-0819-2026

    CGMP Deviations

    Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12. — Baxter Healthcare Corporation

    Medicine pages: Vasopressin

52. August 6, 2026 · Class II · Ongoing · D-0818-2026

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 43066- — Baxter Healthcare Corporation

    Medicine pages: Clindamycin

53. August 6, 2026 · Class II · Ongoing · D-0817-2026

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-4 — Baxter Healthcare Corporation

    Medicine pages: Clindamycin

54. August 6, 2026 · Class II · Ongoing · D-0816-2026

    CGMP Deviations

    Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-95 — Baxter Healthcare Corporation

    Medicine pages: Clindamycin

55. August 6, 2026 · Class II · Ongoing · D-0815-2026

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50. — Baxter Healthcare Corporation

    Medicine pages: Clindamycin

56. August 6, 2026 · Class II · Ongoing · D-0814-2026

    CGMP Deviations

    Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC 430 — Baxter Healthcare Corporation

    Medicine pages: Amiodarone hydrochloride

57. August 6, 2026 · Class II · Ongoing · D-0813-2026

    CGMP Deviations

    CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA — Baxter Healthcare Corporation

    Medicine pages: Nicardipine

58. August 6, 2026 · Class II · Ongoing · D-0812-2026

    CGMP Deviations

    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338-96 — Baxter Healthcare Corporation

    Medicine pages: Pantoprazole sodium

59. August 6, 2026 · Class II · Ongoing · D-0811-2026

    CGMP Deviations

    Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12. — Baxter Healthcare Corporation

    Medicine pages: Vasopressin

60. August 6, 2026 · Class II · Ongoing · D-0810-2026

    CGMP Deviations

    Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12. — Baxter Healthcare Corporation

    Medicine pages: Dexmedetomidine

61. August 6, 2026 · Class II · Ongoing · D-0809-2026

    CGMP Deviations

    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338- — Baxter Healthcare Corporation

    Medicine pages: Famotidine

62. August 6, 2026 · Class II · Ongoing · D-0808-2026

    CGMP Deviations

    Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50. — Baxter Healthcare Corporation

    Medicine pages: Clindamycin

63. August 6, 2026 · Class II · Ongoing · D-0807-2026

    CGMP Deviations

    Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 — Baxter Healthcare Corporation

    Medicine pages: Daptomycin

64. August 6, 2026 · Class II · Ongoing · D-0806-2026

    CGMP Deviations

    MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12. — Baxter Healthcare Corporation

    Medicine pages: Insulin human

65. August 6, 2026 · Class II · Ongoing · D-0805-2026

    CGMP Deviations

    Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48. — Baxter Healthcare Corporation

    Medicine pages: Vancomycin

66. August 6, 2026 · Class II · Ongoing · D-0803-2026

    Presence of particulate matter: glass and stopper piece

    Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2 — Mallinckrodt Hospital Products Inc.

    Medicine pages: Repository corticotropin

67. August 6, 2026 · Class II · Ongoing · D-0786-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-2 — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

68. August 6, 2026 · Class II · Ongoing · D-0785-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

69. August 6, 2026 · Class II · Ongoing · D-0784-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 276 — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

70. August 6, 2026 · Class II · Ongoing · D-0783-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

71. August 6, 2026 · Class II · Ongoing · D-0782-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, M — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

72. August 6, 2026 · Class II · Ongoing · D-0781-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

73. August 6, 2026 · Class II · Ongoing · D-0780-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehrad — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

74. August 6, 2026 · Class II · Ongoing · D-0779-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617 — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

75. August 6, 2026 · Class II · Ongoing · D-0778-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

76. August 6, 2026 · Class II · Ongoing · D-0777-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

77. August 6, 2026 · Class II · Ongoing · D-0776-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

78. August 6, 2026 · Class II · Ongoing · D-0775-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

79. August 5, 2026 · Class I · Ongoing · D-0851-2026

    Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

    Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2204 — OPTIMAL BALANCE PHARMACY

80. August 5, 2026 · Class II · Ongoing · D-0745-2026

    CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

    Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710- — Zydus Pharmaceuticals (USA) Inc

    Medicine pages: Mirabegron

81. August 4, 2026 · Class I · Ongoing · D-0788-2026

    Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

    Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale N — Fresenius Kabi USA, LLC

    Medicine pages: Morphine sulfate

82. August 4, 2026 · Class II · Ongoing · D-0746-2026

    Failed Dissolution Specifications

    Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34 — Novartis Pharmaceuticals Corporation

    Medicine pages: Valsartan

83. August 3, 2026 · Class II · Ongoing · D-0789-2026

    Failed content uniformity specifications.

    Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04. — Lupin Pharmaceuticals Inc.

    Medicine pages: Clobetasol propionate

84. August 3, 2026 · Class II · Ongoing · D-0770-2026

    CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing

    Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51 — SUN PHARMACEUTICAL INDUSTRIES INC

    Medicine pages: Carbamazepine

85. August 3, 2026 · Class II · Ongoing · D-0763-2026

    CGMP Deviations:Noted during FDA inspection

    SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 3827 — Shoolin Pharma Chem LLP

86. August 3, 2026 · Class II · Ongoing · D-0762-2026

    CGMP Deviations:Noted during FDA inspection

    TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, India, — Shoolin Pharma Chem LLP

87. August 3, 2026 · Class II · Ongoing · D-0761-2026

    CGMP Deviations:Noted during FDA inspection

    TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, In — Shoolin Pharma Chem LLP

88. August 3, 2026 · Class II · Ongoing · D-0760-2026

    CGMP Deviations:Noted during FDA inspection

    TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, Indi — Shoolin Pharma Chem LLP

89. August 3, 2026 · Class II · Ongoing · D-0759-2026

    CGMP Deviations:Noted during FDA inspection

    SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 3827 — Shoolin Pharma Chem LLP

July 2026

1. July 31, 2026 · Class I · Ongoing · D-0773-2026

   Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.

   Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Made i — Liebel-Flarsheim Company LLC

   Medicine pages: Ioversol

2. July 30, 2026 · Class II · Ongoing · D-0768-2026

   Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

   CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51 — Heritage Pharmaceuticals Inc

   Medicine pages: Clindamycin palmitate hydrochloride

3. July 29, 2026 · Class II · Ongoing · D-0766-2026

   Lack of assurance of sterility. The recall is due to potential contamination

   CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3 — Prestige Brands Holdings

4. July 29, 2026 · Class II · Ongoing · D-0765-2026

   Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

   PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: — Shilpa Medicare Limited

   Medicine pages: Pemetrexed

5. July 29, 2026 · Class II · Ongoing · D-0764-2026

   Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

   PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC — Shilpa Medicare Limited

   Medicine pages: Pemetrexed

6. July 29, 2026 · Class II · Ongoing · D-0757-2026

   Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

   SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04. — Apollo Care, LLC

7. July 29, 2026 · Class II · Ongoing · D-0756-2026

   Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

   SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02 — Apollo Care, LLC

8. July 29, 2026 · Class II · Ongoing · D-0755-2026

   Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

   SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01 — Apollo Care, LLC

9. July 29, 2026 · Class II · Ongoing · D-0754-2026

   Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

   SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03 — Apollo Care, LLC

10. July 29, 2026 · Class II · Ongoing · D-0753-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02 — Apollo Care, LLC

11. July 29, 2026 · Class II · Ongoing · D-0752-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01 — Apollo Care, LLC

12. July 29, 2026 · Class II · Ongoing · D-0751-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02 — Apollo Care, LLC

13. July 29, 2026 · Class II · Ongoing · D-0750-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03 — Apollo Care, LLC

14. July 29, 2026 · Class II · Ongoing · D-0749-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01 — Apollo Care, LLC

15. July 29, 2026 · Class II · Ongoing · D-0748-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02 — Apollo Care, LLC

16. July 29, 2026 · Class II · Ongoing · D-0747-2026

    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material

    SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05 — Apollo Care, LLC

17. July 29, 2026 · Class II · Ongoing · D-0012-2027

    Failed stability specifications

    Biospectra Tris/Tromethamine, USP, GMP, API Grade, Manufactured at 100 Majestic Way, Bangor, PA 18013, NDC 64173-101-25 — BioSpectra, Inc.

18. July 28, 2026 · Class II · Ongoing · D-0767-2026

    Lack of Assurance of Sterility

    Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regener — Regeneron Pharmaceuticals Inc

    Medicine pages: Cemiplimab-rwlc

19. July 27, 2026 · Not Yet Classified · Ongoing · N/A

    Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

    Tri-Immune Boost (Glutathione: 200 mg, Ascorbic Acid: 200 mg, Zinc: 2.5 mg), 30 mL vial, Rx only, Centric Compounding, 7447 Harwin Dr. Suite 111, Houston, TX 77036 — Centric Compounding LLC

20. July 24, 2026 · Class II · Ongoing · D-0802-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, M — American Regent, Inc.

    Medicine pages: Nicardipine

21. July 24, 2026 · Class II · Ongoing · D-0801-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

    Medicine pages: Trace elements injection 4

22. July 24, 2026 · Class I · Ongoing · D-0800-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde

    Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

23. July 24, 2026 · Class II · Ongoing · D-0799-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY, N — American Regent, Inc.

    Medicine pages: Trace elements injection 4

24. July 24, 2026 · Class II · Ongoing · D-0798-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLE — American Regent, Inc.

    Medicine pages: Selenious acid

25. July 24, 2026 · Class II · Ongoing · D-0797-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

    Medicine pages: Acetylcysteine

26. July 24, 2026 · Class II · Ongoing · D-0796-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967. — American Regent, Inc.

    Medicine pages: Acetylcysteine

27. July 24, 2026 · Class II · Ongoing · D-0795-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, — American Regent, Inc.

    Medicine pages: Atropine

28. July 24, 2026 · Class II · Ongoing · D-0794-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc. — American Regent, Inc.

    Medicine pages: Aminocaproic acid

29. July 24, 2026 · Class II · Ongoing · D-0793-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGENT, — American Regent, Inc.

    Medicine pages: Cyanocobalamin

30. July 24, 2026 · Class II · Ongoing · D-0792-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11 — American Regent, Inc.

    Medicine pages: Cyanocobalamin

31. July 24, 2026 · Class II · Ongoing · D-0791-2026

    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

    Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967. — American Regent, Inc.

    Medicine pages: Nitroglycerin

32. July 24, 2026 · Class I · Ongoing · D-0787-2026

    Presence of Particulate Matter

    Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6001 — Baxter Healthcare Corporation

    Medicine pages: Cefazolin

33. July 24, 2026 · Class II · Ongoing · D-0774-2026

    Failed Dissolution Specifications

    Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80. — Mylan Pharmaceuticals Inc

    Medicine pages: Acamprosate calcium

34. July 23, 2026 · Class II · Ongoing · D-0733-2026

    shortfill; reports of empty capsules.

    Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99 — Aurobindo Pharma USA Inc

    Medicine pages: Dicyclomine hydrochloride

35. July 23, 2026 · Class II · Ongoing · D-0731-2026

    CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.

    Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA, Elmwood Park, NJ 07407, NDC 68462-626-52. — Glenmark Pharmaceuticals Inc., USA

    Medicine pages: Azelaic acid

36. July 22, 2026 · Class II · Ongoing · D-0730-2026

    Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.

    Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL - bottle, Rx only, Manufactured by: Micro Labs Limited, India, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873. NDC 42571-147-26. — MICRO LABS USA INC

    Medicine pages: Dorzolamide hydrochloride and timolol maleate

37. July 17, 2026 · Class I · Ongoing · D-0744-2026

    Presence of Particulate Matter; identified as stainless steel

    Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1 — Sunny Pharmtech Inc.

38. July 17, 2026 · Class I · Ongoing · D-0743-2026

    Presence of Particulate Matter; identified as stainless steel

    Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1 — Sunny Pharmtech Inc.

39. July 16, 2026 · Class III · Ongoing · D-0740-2026

    Incorrect Product Formulation

    Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., A — Central Admixture Pharmacy Services Inc

40. July 16, 2026 · Class III · Ongoing · D-0739-2026

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4 — Ascend Laboratories, LLC

    Medicine pages: Dabigatran etexilate

41. July 16, 2026 · Class III · Ongoing · D-0738-2026

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46 — Ascend Laboratories, LLC

    Medicine pages: Dabigatran etexilate

42. July 16, 2026 · Class III · Ongoing · D-0737-2026

    Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability

    Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN — Ascend Laboratories, LLC

    Medicine pages: Dabigatran etexilate

43. July 16, 2026 · Class II · Ongoing · D-0729-2026

    Presence of Particulate Matter: Hair was found in products

    Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-57; NDC Vial: 63323-485-03 — Fresenius Kabi USA, LLC

    Medicine pages: Lidocaine hydrochloride,epinephrine bitartrate, Lidocaine

44. July 16, 2026 · Class II · Ongoing · D-0728-2026

    Presence of Particulate Matter: Hair was found in products

    Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-485-27; NDC Vial: 63323-485-01 — Fresenius Kabi USA, LLC

    Medicine pages: Lidocaine hydrochloride,epinephrine bitartrate, Lidocaine

45. July 16, 2026 · Class II · Ongoing · D-0727-2026

    Presence of Particulate Matter: Hair was found in products

    Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial: 63323-286-0 — Fresenius Kabi USA, LLC

    Medicine pages: Ropivacaine hydrochloride

46. July 16, 2026 · Class II · Ongoing · D-0726-2026

    Presence of Particulate Matter: Hair was found in products

    Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-208-05; NDC Vial: 63323-208-01 — Fresenius Kabi USA, LLC

    Medicine pages: Lidocaine

47. July 16, 2026 · Class II · Ongoing · D-0725-2026

    Presence of Particulate Matter: Hair was found in product

    Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-578-05; NDC Vial: 63323-578-07 — Fresenius Kabi USA, LLC

    Medicine pages: Glycopyrrolate

48. July 15, 2026 · Class III · Ongoing · D-0713-2026

    Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

    Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only, Distributed by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-760-01. — Asclemed USA Inc.

    Medicine pages: Lidocaine, Triamcinolone acetonide

49. July 14, 2026 · Class II · Ongoing · D-0741-2026

    Failed Impurities/Degradation Specifications

    Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precision Dose, Inc, S. Beloil, IL 61080, unit-dose oral syringes, NDCs 68094-073-01 (oral syringe) and 68094-073-58 (case). — Precision Dose Inc.

    Medicine pages: Glycopyrrolate

50. July 14, 2026 · Class II · Ongoing · D-0722-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 31074201 — Rohto-Mentholatum (Vietnam) Co., Ltd.

51. July 14, 2026 · Class II · Ongoing · D-0721-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC — Rohto-Mentholatum (Vietnam) Co., Ltd.

52. July 14, 2026 · Class II · Ongoing · D-0720-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1 — Rohto-Mentholatum (Vietnam) Co., Ltd.

53. July 14, 2026 · Class II · Ongoing · D-0719-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742 — Rohto-Mentholatum (Vietnam) Co., Ltd.

54. July 14, 2026 · Class II · Ongoing · D-0718-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UP — Rohto-Mentholatum (Vietnam) Co., Ltd.

55. July 14, 2026 · Class II · Ongoing · D-0717-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 31 — Rohto-Mentholatum (Vietnam) Co., Ltd.

56. July 14, 2026 · Class II · Ongoing · D-0716-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011012, — Rohto-Mentholatum (Vietnam) Co., Ltd.

57. July 14, 2026 · Class II · Ongoing · D-0715-2026

    Lack of Assurance of Sterility

    Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 3107 — Rohto-Mentholatum (Vietnam) Co., Ltd.

58. July 13, 2026 · Class II · Ongoing · D-0724-2026

    Presence of Precipitate: medication was crystallizing and particles floating in the bottle

    Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ, Manufactured by: Lyne Laboratories, Inc., Brockton, MA. NDC 64980-504- — Rising Pharma Holding, Inc.

    Medicine pages: Cyproheptadine

59. July 13, 2026 · Class II · Ongoing · D-0711-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal — Major Pharmaceuticals

    Medicine pages: Levothyroxine

60. July 13, 2026 · Class II · Ongoing · D-0710-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal — Major Pharmaceuticals

    Medicine pages: Levothyroxine

61. July 13, 2026 · Class II · Ongoing · D-0709-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals

    Medicine pages: Levothyroxine

62. July 13, 2026 · Class II · Ongoing · D-0708-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals

    Medicine pages: Levothyroxine

63. July 13, 2026 · Class II · Ongoing · D-0707-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He — Major Pharmaceuticals

    Medicine pages: Levothyroxine

64. July 13, 2026 · Class II · Ongoing · D-0706-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6956-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

65. July 13, 2026 · Class II · Ongoing · D-0705-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6955-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

66. July 13, 2026 · Class II · Ongoing · D-0704-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

67. July 13, 2026 · Class II · Ongoing · D-0703-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6952-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

68. July 13, 2026 · Class II · Ongoing · D-0702-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6951-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

69. July 13, 2026 · Class II · Ongoing · D-0701-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6950-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

70. July 13, 2026 · Class II · Ongoing · D-0700-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6949-61 — Major Pharmaceuticals

    Medicine pages: Levothyroxine

71. July 9, 2026 · Class II · Ongoing · D-0690-2026

    Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL applicators/carton, 0.03fl oz (1 mL) each, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, D — CareFusion 213, LLC

72. July 8, 2026 · Class II · Ongoing · D-0712-2026

    Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications

    Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC., Parsnippany, NJ 07054. NDC: 67877-500- — Ascend Laboratories, LLC

    Medicine pages: Amlodipine and olmesartan medoxomil

73. July 6, 2026 · Class III · Ongoing · D-0758-2026

    Failed Dissolution Specifications

    Trokendi XR, topiramate extended-release capsules, 25mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 20850 U — Supernus Pharmaceuticals, Inc.

    Medicine pages: Topiramate

74. July 6, 2026 · Class II · Ongoing · D-0689-2026

    Lack of Assurance of Sterility

    CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Single Use Vials, Rx Only, Manufactured for: Chiesi USA, Inc., Cary, NC 27518, by Fresenius Kabi, Graz, Austria, NDC 10122-611-10. — Chiesi USA, Inc.

    Medicine pages: Clevipidine

75. July 2, 2026 · Class II · Ongoing · D-0734-2026

    Presence of precipitate

    Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & ND — MYLAN PHARMACEUTICALS INC

    Medicine pages: Mycophenolate mofetil

76. July 1, 2026 · Class I · Ongoing · D-0772-2026

    Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.

    Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC. — Victory Medical Center Pharmacy

June 2026

1. June 30, 2026 · Class III · Ongoing · D-0736-2026

   Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

   Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. — Ascend Laboratories, LLC

   Medicine pages: Dabigatran etexilate

2. June 30, 2026 · Class III · Ongoing · D-0735-2026

   Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

   Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68. — Ascend Laboratories, LLC

   Medicine pages: Dabigatran etexilate

3. June 29, 2026 · Class II · Ongoing · D-0676-2026

   cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

   Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

   Medicine pages: Cinacalcet

4. June 29, 2026 · Class II · Ongoing · D-0675-2026

   cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

   Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

   Medicine pages: Cinacalcet

5. June 29, 2026 · Class II · Ongoing · D-0661-2026

   cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).

   Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 6909 — Cipla USA, Inc.

   Medicine pages: Cinacalcet

6. June 26, 2026 · Class II · Ongoing · D-0742-2026

   Presence of Foreign Tablets/Capsules

   Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, Made in India, NDC 69452-435-30. — Bionpharma Inc.

   Medicine pages: Divalproex sodium

7. June 26, 2026 · Class II · Ongoing · D-0660-2026

   Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.

   Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules, 5 mg, Rx Only, 100 capsules, Distributed by: Lannett Company, Inc., Philadelph — Lannett Company Inc.

   Medicine pages: Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

8. June 25, 2026 · Class II · Ongoing · D-0688-2026

   SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

   CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34, DISTRIBUTED BY: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785. — Bell Pharmaceuticals, Inc

9. June 25, 2026 · Class II · Ongoing · D-0687-2026

   SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

   meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC 41250-835-33, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. — Bell Pharmaceuticals, Inc

10. June 25, 2026 · Class II · Ongoing · D-0686-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-01, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141. — Bell Pharmaceuticals, Inc

11. June 25, 2026 · Class II · Ongoing · D-0685-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYRINGE, 0.5 FL OZ DROPS, (NDC 70000-0689-1); b) 1 bottle (NDC 70000-0688-1), DIST. BY CARDINAL HEALTH, DUBLIN, OH 43017. — Bell Pharmaceuticals, Inc

12. June 25, 2026 · Class II · Ongoing · D-0684-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - Washer Bulb Included, (NDC 46122-556-05); b) 1 bottle (NDC 46122-557-05), Distributed by: AmerisourceBergen, 1 West First Avenue, Conshohocken, — Bell Pharmaceuticals, Inc

13. June 25, 2026 · Class II · Ongoing · D-0683-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bulb Included, (NDC 55319-835-01), DISTRIBUTED BY: MIDWOOD BRANDS LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320. — Bell Pharmaceuticals, Inc

14. June 25, 2026 · Class II · Ongoing · D-0682-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Washer Bulb Included (NDC 59256-001-02); b) 1 bottle (NDC 59256-836-34), Distributed By: Oaktree Products Inc., St. Louis. MO 63005. — Bell Pharmaceuticals, Inc

15. June 25, 2026 · Class II · Ongoing · D-0681-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BULB & DROPS INCLUDED (NDC 36800-835-33); b) 1 bottle (NDC 36800-835-34), DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. — Bell Pharmaceuticals, Inc

16. June 25, 2026 · Class II · Ongoing · D-0680-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bulb included (NDC 63868-026-15); b) 1 bottle (NDC 63868-027-16), Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376. — Bell Pharmaceuticals, Inc

17. June 25, 2026 · Class II · Ongoing · D-0679-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x 0.50 mL) 6.5%, 0.5 fl. oz. (15 mL); b) 1 bottle of Clinere Carbamide Peroxide (0,50 fl. oz. (15 mL), Dist. by: Quest Products LLC, Pleasant Pra — Bell Pharmaceuticals, Inc

18. June 25, 2026 · Class II · Ongoing · D-0678-2026

    SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).

    CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316-822-00.); b) Kit (1 BULB, Syringe & Drops- NDC 51316-823-00.), Distributed by: CVS Pharmacy., Inc. One CVS Drive, Woonsocket, RI 02895, — Bell Pharmaceuticals, Inc

19. June 24, 2026 · Class I · Ongoing · D-0732-2026

    Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.

    Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings — JB Chemicals and Pharmaceuticals Ltd

20. June 24, 2026 · Class II · Ongoing · D-0674-2026

    Lack of Sterility Assurance

    Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For Subcutaneous and Intravenous Use, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0857-01 — Reliance Life Sciences Private Limited

21. June 24, 2026 · Class II · Ongoing · D-0673-2026

    Lack of Sterility Assurance

    Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intravenous or Subcutaneous Use, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873. NDC: 70069-0836-01 — Reliance Life Sciences Private Limited

22. June 24, 2026 · Class II · Ongoing · D-0672-2026

    Lack of Sterility Assurance

    Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0835-01 — Reliance Life Sciences Private Limited

23. June 24, 2026 · Class II · Ongoing · D-0671-2026

    Lack of Sterility Assurance

    Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For intravenous use only, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873 NDC: 70069-0834-01 — Reliance Life Sciences Private Limited

24. June 24, 2026 · Class II · Ongoing · D-0664-2026

    Failed Impurities/Degradation Specifications

    Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46. — QuVa Pharma, Inc.

25. June 23, 2026 · Class II · Ongoing · D-0723-2026

    CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.

    Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin L — Lupin Pharmaceuticals Inc.

26. June 23, 2026 · Class II · Ongoing · D-0677-2026

    Subpotent Drug: Low out of specification assay results performed during long-term stability testing.

    Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35 — Padagis US LLC

    Medicine pages: Nystatin

27. June 22, 2026 · Class II · Ongoing · D-0617-2026

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx. — Direct Rx

28. June 17, 2026 · Class II · Ongoing · D-0628-2026

    Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.

    Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 51672-4206-6 — SUN PHARMACEUTICAL INDUSTRIES INC

    Medicine pages: Perampanel

29. June 16, 2026 · Class II · Ongoing · D-0609-2026

    Subpotent Drug

    Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonov — The Harvard Drug Group LLC

    Medicine pages: Methylergonovine maleate

30. June 12, 2026 · Class II · Ongoing · D-0657-2026

    CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.

    Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per Bottle, Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA — Boehringer Ingelheim Pharmaceuticals, Inc.

31. June 12, 2026 · Class II · Ongoing · D-0596-2026

    Crystallization; identified as Buprenorphine free base

    Buprenorphine HCl, CIII, Injection, 0.3 mg/mL, 5 x 1 mL Single Dose Vials per Carton, Rx Only, For Intramuscular or Intravenous use, Manufactured for: Endo USA, Malvern, PA 19355, NDC 42023-179-05 — Par Health USA, LLC

    Medicine pages: Buprenorphine

32. June 11, 2026 · Class II · Ongoing · D-0663-2026

    Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.

    Medline Remedy Specialized Silicone Cream (Hydraguard-D ),Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 80090 2 FL OZ (59 mL) NDC 53329-159-13 4 FL OZ (118 mL) NDC 53329-159-04 — BioMed Laboratories, LLC.

33. June 11, 2026 · Class II · Ongoing · D-0652-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 100 x 10.5 mL Applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 543 — CareFusion 213, LLC

34. June 11, 2026 · Class II · Ongoing · D-0651-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep CLear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol),500 x 1 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC 54365- — CareFusion 213, LLC

35. June 11, 2026 · Class II · Ongoing · D-0650-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 25 x 26 mL applicators/case, NDC 54365-400-39, catalog number 930825NS, b) 50 x 26 mL applicators/case, NDC 54 — CareFusion 213, LLC

36. June 11, 2026 · Class II · Ongoing · D-0649-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Scrub Teal, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 10.5 mL Applicators/case, NDC 54365-400-36, catalog number 930725NS; b) 100 x 10.5 mL Applicators/case, — CareFusion 213, LLC

37. June 11, 2026 · Class II · Ongoing · D-0648-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as: a) 25 x 26 mL applicators/case, NDC 54365-400-38, calatog number 930815NS: b) 50 x 26 mL appliactors/case, b — CareFusion 213, LLC

38. June 11, 2026 · Class II · Ongoing · D-0647-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) packaged as a) 100 x 3 mL applicators/case, NDC 54365-400-33, calatog 930415NS: b) 250 x 3mL applicators/case, bulk catal — CareFusion 213, LLC

39. June 11, 2026 · Class II · Ongoing · D-0646-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    ChloraPrep FREPP, Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol) 500 x 1.5 mL applicators/case, STERILE SOLUTION, CareFusion 123, LLC, El Paso, TX, subsidiary of Beckton, Dickson and Co. NDC — CareFusion 213, LLC

40. June 11, 2026 · Class II · Ongoing · D-0645-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG), and 70% v/v isopropyl alcohol (IPA), Packaged as a) 100 x 3ml applicators/case, NDC 54365-400-32, catalog 930400NS; b) 250 x 3ml applicators/case, NDC 54365-400 — CareFusion 213, LLC

41. June 11, 2026 · Class II · Ongoing · D-0644-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD PurPrep, (Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w), 50 x 26 mL Applicator/case, STERILE SOLUTION, CAREFUSION 213, LLC, EL PASO, TX 79912, subsidiary of Beckton, Dickson and C — CareFusion 213, LLC

42. June 11, 2026 · Class II · Ongoing · D-0643-2026

    Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel

    BD ChloraPrep Hi-Lite Orange, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), packaged as a) 100 x 10.5 mL applicators/case, NDC 54365-400-35, Catalog Number: 930715NS; b) 100 x 10.5 mL applic — CareFusion 213, LLC

43. June 10, 2026 · Class II · Ongoing · D-0714-2026

    Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.

    Gemcitabine Injection, 1 g per 26.3 mL (38 mg/mL), 26.3 mL Single-Dose Vial, For Intravenous Infusion ONLY, Rx only, Manufactured by: THYMOORGAN PHARMAZIE GmbH, Schiffgraben 23, 38690 Goslar, Germany; Distributed by: Hik — McKesson

    Medicine pages: Gemcitabine

44. June 10, 2026 · Class II · Ongoing · D-0653-2026

    Lack of assurance of Sterility:

    IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Ind — ACCORD BIOPHARMA INC

    Medicine pages: Ustekinumab-srlf

45. June 8, 2026 · Class II · Ongoing · D-0659-2026

    Lack of Assurance of Sterility

    Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 85766-187-01. — Asclemed USA Inc.

    Medicine pages: Lidocaine

46. June 8, 2026 · Class II · Ongoing · D-0658-2026

    Lack of Assurance of Sterility

    Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by Enovachem Pharmaceuticals, Torrance, CA 90501, NDC: 76420-715-01. — Asclemed USA Inc.

47. June 8, 2026 · Class II · Ongoing · D-0656-2026

    Subpotent Drug

    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: lntas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun- — ACCORD HEALTHCARE, INC.

    Medicine pages: Levothyroxine

48. June 7, 2026 · Class II · Ongoing · D-0662-2026

    Failed Impurities/Degradation Specifications

    Methohexital Sodium for Injection, USP 500 mg Multiple Dose Vial, Rx Only, Manufactured by: OneSource Specialty, Pharma Limited, Bengaluru - 561 203, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ — ONESOURCE SPECIALTY PHARMA LIMITED

    Medicine pages: Methohexital sodium

49. June 5, 2026 · Class II · Ongoing · D-0610-2026

    Failed Dissolution Specifications

    Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA. Distributed by: Risiong Pharma — Inventia Healthcare Limited

    Medicine pages: Chlorthalidone

50. June 4, 2026 · Class II · Ongoing · D-0655-2026

    Presence of Foreign Substance

    prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA — Lupin Pharmaceuticals Inc.

    Medicine pages: Prednisolone acetate

51. June 4, 2026 · Class II · Ongoing · D-0627-2026

    sub potency

    Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1. — Elevate Oral Care

52. June 4, 2026 · Class II · Ongoing · D-0626-2026

    Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.

    Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma Pvt., Ltd, Sangareddy -502313, Telangana, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-813-60. — Annora Pharma Private Limited

    Medicine pages: Lacosamide

53. June 4, 2026 · Class II · Ongoing · D-0616-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks, CA 91320-1799, Made in Japan. NDC 55513-075-30 — Amgen, Inc.

    Medicine pages: Cinacalcet

54. June 4, 2026 · Class II · Ongoing · D-0615-2026

    Presence of Foreign Substance.

    Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60 — Amgen, Inc.

    Medicine pages: Ivabradine

55. June 4, 2026 · Class II · Ongoing · D-0614-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-074-30 — Amgen, Inc.

    Medicine pages: Cinacalcet

56. June 4, 2026 · Class II · Ongoing · D-0613-2026

    CGMP Deviations

    Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: Amge, One Amgen Center Drive, Thousand Oaks ,CA 91320-1799, Made in Japan. NDC 55513-073-30 — Amgen, Inc.

    Medicine pages: Cinacalcet

57. June 4, 2026 · Class II · Ongoing · D-0612-2026

    Presence of Foreign Substance.

    Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. — Amgen, Inc.

    Medicine pages: Ivabradine

58. June 4, 2026 · Class I · Ongoing · D-0595-2026

    Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

    Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. — Haleon US Holdings LLC

59. June 4, 2026 · Class II · Ongoing · D-0583-2026

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by — Breckenridge Pharmaceutical, Inc.

    Medicine pages: Duloxetine

60. June 4, 2026 · Class II · Ongoing · D-0582-2026

    CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

    Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berke — Breckenridge Pharmaceutical, Inc.

    Medicine pages: Duloxetine

61. June 3, 2026 · Class III · Ongoing · D-0585-2026

    Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

    Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, — Amneal Pharmaceuticals, LLC

    Medicine pages: Primidone

62. June 2, 2026 · Class II · Ongoing · D-0642-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 5 mg, Polymyxin B 5000 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, U — Dabur India Limited

63. June 2, 2026 · Class II · Ongoing · D-0641-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 units), Neomycin Sulfate 5 mg, Polymixin B 5000 units, 0.9g packets, 144 packets per box, 130g, Manufactured for: Shield Line LLC, 59 Hook Road, B — Dabur India Limited

64. June 2, 2026 · Class II · Ongoing · D-0640-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0. — Dabur India Limited

65. June 2, 2026 · Class II · Ongoing · D-0639-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 305061. — Dabur India Limited

66. June 2, 2026 · Class II · Ongoing · D-0638-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 524103 0244 2. — Dabur India Limited

67. June 2, 2026 · Class II · Ongoing · D-0637-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC X004WB4LKT. — Dabur India Limited

68. June 2, 2026 · Class II · Ongoing · D-0636-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30354 8. — Dabur India Limited

69. June 2, 2026 · Class II · Ongoing · D-0635-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144 count box, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30352 4. — Dabur India Limited

70. June 2, 2026 · Class II · Ongoing · D-0634-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1. — Dabur India Limited

71. June 2, 2026 · Class II · Ongoing · D-0633-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neomycin Sulfate 3.5 mg, Polymyxin-B Sulfate 5,000 units, net wt. 2oz (57g) tubes, Distributed by/por: Pharmadel LLC, New Castle, DE 19720, Made i — Dabur India Limited

72. June 2, 2026 · Class II · Ongoing · D-0632-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g), Product distributed by: Lil' Drug Store Products, Inc., 9300 E — Dabur India Limited

73. June 2, 2026 · Class II · Ongoing · D-0631-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin Sulfate (3.5 mg), Polymyxin-B Sulfate (5000 units), net wt. 0.5 oz (14.2g) tubes, Product manufactured for Lil' Drug Store Products, Inc., 9300 — Dabur India Limited

74. June 2, 2026 · Class II · Ongoing · D-0630-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 units, neomycin sulphate 3.5 mg, polymyxin B sulphate 5000 units, Net Wt. 0.5 oz (14g) tubes, Manufactured for Delta Brands Inc., 580 White Plai — Dabur India Limited

75. June 2, 2026 · Class II · Ongoing · D-0629-2026

    CGMP Deviations; deficiencies observed during FDA inspection

    Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes, Manufactured for Delta Brands Inc., 580 White Plains Rd., Tarrytown, NY 10591 USA, Made in India, UPC 8 08829 10461 — Dabur India Limited

76. June 2, 2026 · Class III · Ongoing · D-0619-2026

    Presence of foreign substance

    hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10 — ANI Pharmaceuticals, Inc.

    Medicine pages: Hydroxyzine

77. June 2, 2026 · Class II · Ongoing · D-0618-2026

    Incorrect product formulation: bag did not contain copper and famotidine per label.

    Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Rx# 24-1269856-0-1Compound Volume 1295 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy — Central Admixture Pharmacy Services, Inc.

78. June 1, 2026 · Class III · Ongoing · D-0654-2026

    Failed Impurities/Degradation Specifications

    Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswick, NJ 08901. NDC 66336-561-30 — SUN PHARMACEUTICAL INDUSTRIES INC

79. June 1, 2026 · Class I · Ongoing · D-0620-2026

    Microbial Contamination of Non-Sterile Products

    BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Propolis + Xylitol, 1 FL OZ (30 mL) per bottle, Manufactured For: Beekeeper's Naturals USA Inc., Covina, CA 91789. — BEEKEEPER'S NATURALS USA INC.

80. June 1, 2026 · Class III · Ongoing · D-0608-2026

    Labeling: Incorrect or Missing Lot and/or Exp Date

    Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31 — Sandoz Inc

    Medicine pages: Dexmethylphenidate hydrochloride

81. June 1, 2026 · Class II · Ongoing · D-0597-2026

    Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

    Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-3 — Ascend Laboratories, LLC

    Medicine pages: Minocycline hydrochloride

May 2026

1. May 29, 2026 · Class II · Ongoing · D-0670-2026

   Subpotent drug

   Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana Llana Rio Piedras, PR 00924, UPC 659685696567. — Gasco Industrial Corp.

2. May 29, 2026 · Class II · Ongoing · D-0669-2026

   Subpotent drug

   Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924, UPC 69685696529 — Gasco Industrial Corp.

3. May 29, 2026 · Class II · Ongoing · D-0668-2026

   Subpotent drug

   Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), Distributed by: Drogueria San Juan, Calle De Diego 590, Sabana LLana Rio Piedras, PR 00924 — Gasco Industrial Corp.

4. May 29, 2026 · Class II · Ongoing · D-0667-2026

   Subpotent drug

   Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6. — Gasco Industrial Corp.

5. May 29, 2026 · Class II · Ongoing · D-0666-2026

   Subpotent drug

   Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured by: Gasco Industrial Corp., PO Box 1360, Gurabo, PR 00778, Made in USA — Gasco Industrial Corp.

6. May 29, 2026 · Class II · Ongoing · D-0665-2026

   Subpotent drug

   Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: Gasco Industrial Corp., PO Box 1360 Gurabo PR 00778 Made in USA UPC 7 87302 13044 3 — Gasco Industrial Corp.

7. May 29, 2026 · Class II · Ongoing · D-0607-2026

   Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution

   Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactur — SUN PHARMACEUTICAL INDUSTRIES INC

   Medicine pages: Budesonide

8. May 29, 2026 · Class II · Ongoing · D-0587-2026

   Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.

   GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, — Golden State Medical Supply Inc.

   Medicine pages: Niacin

9. May 28, 2026 · Class I · Ongoing · D-0625-2026

   Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

   BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC

10. May 28, 2026 · Class I · Ongoing · D-0624-2026

    Non-Sterility: Due to presence of Aspergillus penicillioides.

    BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 1 mL Applicator, 60 Applicators per inner Carton, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of B — CareFusion 213, LLC

11. May 28, 2026 · Class II · Ongoing · D-0623-2026

    Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1.5 mL Applicator, 20 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Di — CareFusion 213, LLC

12. May 28, 2026 · Class II · Ongoing · D-0622-2026

    Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.

    BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) 1 mL Applicator, 60 Applicators, Sterile Solution, Care Fusion 213, LLC, El Paso, TX 79912, subsidiary of Beckton, Dickinson — CareFusion 213, LLC

13. May 28, 2026 · Class II · Ongoing · D-0611-2026

    CGMP Deviations

    Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807, NDC 27241-120-04. — Ajanta Pharma USA Inc

    Medicine pages: Fenofibrate

14. May 28, 2026 · Class II · Ongoing · D-0579-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-129-68. — Guardian Drug Co. Inc.

15. May 28, 2026 · Class II · Ongoing · D-0578-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY TOPCO ASSOCIATES LLC.,ELK GROVE VILLAGE, IL 60007, NDC 76162-128-22. — Guardian Drug Co. Inc.

16. May 28, 2026 · Class II · Ongoing · D-0577-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-171-68. — Guardian Drug Co. Inc.

17. May 28, 2026 · Class II · Ongoing · D-0576-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewable tablets, DISTRIBUTED BY SUPERVALU INC.,EDEN PRARIE, MN 55344 USA, NDC 41163-129-22. — Guardian Drug Co. Inc.

18. May 28, 2026 · Class II · Ongoing · D-0575-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-171-68. — Guardian Drug Co. Inc.

19. May 28, 2026 · Class II · Ongoing · D-0574-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewable Tablets, Distributed by: Geiss, Destin & Dunn, inc., Peachtree City, GA, NDC 50804-129-22. — Guardian Drug Co. Inc.

20. May 28, 2026 · Class II · Ongoing · D-0573-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750 mg, 96 Chewable Tablets, MADE WITH PRIDE & CARE FOR H.E.B, 646 S. FLORES ST, SAN ANTONIO, TX, NDC 37808-136-22. — Guardian Drug Co. Inc.

21. May 28, 2026 · Class II · Ongoing · D-0572-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82514 5. — Guardian Drug Co. Inc.

22. May 28, 2026 · Class II · Ongoing · D-0571-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DISTRIBUTED BY: HY-VEE INC., Inc., WEST DES MOINES, IA 50266, UPC: 0 75450 82497 1. — Guardian Drug Co. Inc.

23. May 28, 2026 · Class II · Ongoing · D-0570-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, Distributed by: Harris Teeter, LLC.,MATTHEWS, NC 28105, UPC: 0 72036-73108-1. — Guardian Drug Co. Inc.

24. May 28, 2026 · Class II · Ongoing · D-0569-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., UP: 0 32251-92282-4. — Guardian Drug Co. Inc.

25. May 28, 2026 · Class II · Ongoing · D-0568-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS, DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320 USA., NDC 55319-171-68. — Guardian Drug Co. Inc.

26. May 28, 2026 · Class II · Ongoing · D-0567-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg, 96 Tablets, Distributed by: Drug Mart- Food Fair Medina, OH 44256, UPC: 0 93351 03992 8. — Guardian Drug Co. Inc.

27. May 28, 2026 · Class II · Ongoing · D-0566-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-178-23. — Guardian Drug Co. Inc.

28. May 28, 2026 · Class II · Ongoing · D-0565-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable Tablets, Distributed by: FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 72476-127-80. — Guardian Drug Co. Inc.

29. May 28, 2026 · Class II · Ongoing · D-0564-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, Distributed by: De Moules Supermarkets, Inc.,Tewksbury, Mass 01875, UPC 0 49705 83149 6. — Guardian Drug Co. Inc.

30. May 28, 2026 · Class II · Ongoing · D-0563-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 mg, 96 chewable tablets, DISTRIBUTED BY 7-ELEVEN, IRVING, TX 75063, UPC 0 5254863573 2. — Guardian Drug Co. Inc.

31. May 28, 2026 · Class II · Ongoing · D-0562-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count bottle, DISTRIBUTED BY CASEY'S MARKETING COMPANY, ANKENY, IA 50521, UPC: 0 98437 24361 9. — Guardian Drug Co. Inc.

32. May 28, 2026 · Class II · Ongoing · D-0561-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 chewable tablets, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-595-23. — Guardian Drug Co. Inc.

33. May 28, 2026 · Class II · Ongoing · D-0560-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chewable, 96-count bottle, Distributed by: Amerisourcebergen, 1 West First Avenue, Conshohocken, PA, 19428, NDC 24385-106-80. — Guardian Drug Co. Inc.

34. May 28, 2026 · Class II · Ongoing · D-0559-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-count bottle, Haleon, Warren, NJ 07059, UPC 3 0766 3072 10 9. — Guardian Drug Co. Inc.

35. May 28, 2026 · Class II · Ongoing · D-0558-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-count bottle, Haleon, Warren, NJ 07059, UPC 3 07660 74610 2. — Guardian Drug Co. Inc.

36. May 28, 2026 · Class II · Ongoing · D-0557-2026

    Presence of foreign substance: small metallic particles in chewable tablets.

    KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-count bottle, MANUFACTURED BY: GUARDIAN DRUG COMPANY, INC., 2 CHARLES COURT/DAYTON, NJ 08810, FOR: Costco Wholesale Corporation, 999 Lake Drive, — Guardian Drug Co. Inc.

37. May 27, 2026 · Class II · Ongoing · D-0594-2026

    Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.

    Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-056-03. — Ajanta Pharma USA Inc

    Medicine pages: Aripiprazole

38. May 27, 2026 · Class II · Ongoing · D-0588-2026

    Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

    Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals — Glenmark Pharmaceuticals Inc., USA

39. May 27, 2026 · Class II · Ongoing · D-0584-2026

    Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.

    Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 62175-322-46. — Lannett Company Inc.

    Medicine pages: Niacin

40. May 22, 2026 · Class II · Ongoing · D-0599-2026

    Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

    Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-05 — SUN PHARMACEUTICAL INDUSTRIES INC

41. May 22, 2026 · Class II · Ongoing · D-0598-2026

    Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona

    Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPharma, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Fort Bio-Pharma, LLC., Las Vegas, NV 89113, NDC 72245-76 — SUN PHARMACEUTICAL INDUSTRIES INC

42. May 22, 2026 · Class II · Ongoing · D-0586-2026

    Microbial contamination of sterile products

    Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters, Made in USA, A Zep Inc. Brand, Distributed by: Zap Inc., 350 Joe Frank Harris Parkway, SE, Emerson, GA 30137, NDC 66949-133-85. — Zep Inc

43. May 21, 2026 · Class II · Ongoing · D-0606-2026

    Defective container:may contain bottles with incomplete seals

    safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1. — Keystone Industries

44. May 21, 2026 · Class II · Ongoing · D-0605-2026

    Defective container:may contain bottles with incomplete seals

    PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30 — Keystone Industries

45. May 21, 2026 · Class II · Ongoing · D-0604-2026

    Defective container:may contain bottles with incomplete seals

    Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30 — Keystone Industries

46. May 21, 2026 · Class II · Ongoing · D-0603-2026

    Defective container:may contain bottles with incomplete seals

    Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30 — Keystone Industries

47. May 21, 2026 · Class II · Ongoing · D-0602-2026

    Defective container:may contain bottles with incomplete seals

    DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30 — Keystone Industries

48. May 21, 2026 · Class II · Ongoing · D-0601-2026

    Defective container:may contain bottles with incomplete seals

    Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30. — Keystone Industries

49. May 21, 2026 · Class II · Ongoing · D-0600-2026

    Defective container:may contain bottles with incomplete seals

    Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3. — Keystone Industries

50. May 19, 2026 · Class II · Ongoing · D-0691-2026

    cGMP deviations

    Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net Weight a)1 KG (NDC 84849-000-01), b) 500 g (NDC 84849-000-02), (c) 100 g (NDC 84849-000-03), Rx Only, Shimoga Chemicals Address -W-57A, MIDC Ku — Shimoga Chemicals

51. May 18, 2026 · Class II · Ongoing · D-0621-2026

    Lack of Assurance of Sterility

    PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye, LLC, Golden, CO — PReye LLC

52. May 18, 2026 · Class II · Ongoing · D-0593-2026

    Subpotent Drug

    Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compounding Services, LLC. 3650 Victoria St N, Suite 900, Shoreview, MN, NDC 71139-0190-1. — IntegraDose Compounding Services LLC

53. May 18, 2026 · Class III · Ongoing · D-0552-2026

    Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan

    Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520. NDC: 55150-164-02 — Eugia US LLC

    Medicine pages: Lidocaine, Triamcinolone acetonide

54. May 18, 2026 · Class III · Ongoing · D-0551-2026

    Failed Stability Specifications

    PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10. — AbbVie Inc.

    Medicine pages: Prednisolone acetate

55. May 15, 2026 · Class II · Ongoing · D-0592-2026

    Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 52 Grams Sorbitol in 240 mL (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-08. — PAI Holdings LLC

56. May 15, 2026 · Class II · Ongoing · D-0591-2026

    Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

    VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 26 Grams Sorbitol in 120 mL (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-203-04. — PAI Holdings LLC

57. May 15, 2026 · Class II · Ongoing · D-0590-2026

    Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams Activated Charcoal in 240 ml (8 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-08. — PAI Holdings LLC

58. May 15, 2026 · Class II · Ongoing · D-0589-2026

    Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023

    VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams Activated Charcoal in 120 ml (4 fl oz), distributed by: VistaPharm, Inc., Largo. FL 33771, NDC 66689-202-04. — PAI Holdings LLC

59. May 14, 2026 · Class III · Ongoing · D-0581-2026

    Failed Impurities/Degradations Specifications

    Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) — Fresenius Kabi USA, LLC

    Medicine pages: Epinephrine

60. May 14, 2026 · Class II · Ongoing · D-0555-2026

    CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.

    Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem Pharmaceuticals, Torrance, CA 90501, NDC 76420-634-30, Marketed by: Ajanta Pharma USA Inc. — Asclemed USA Inc.

    Medicine pages: Duloxetine

61. May 14, 2026 · Class III · Ongoing · D-0550-2026

    Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.

    Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva, Distributed by: RUGBY LABORATORIES, Indianapolis, IN 46268, www.majorpharmaceuticals.com, NDC 0536-5895-88. — AVEVA Drug Delivery Systems, Inc.

62. May 12, 2026 · Class I · Ongoing · D-0580-2026

    Presence of Particulate matter: Particulate matter identified as glass.

    DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Ba — SUN PHARMACEUTICAL INDUSTRIES INC

    Medicine pages: Doxorubicin hydrochloride

63. May 12, 2026 · Class II · Ongoing · D-0554-2026

    Lack of Assurance of Sterility

    Lidocaine HCl Injection USP, 25x5 mL, Single-Dose Ampules, Rx Only, Distributed by: Spectra Medical Devices, LLC, Wilmington, Made in S. Korea, NDC 65282-1605-1. — Spectra Medical Devices, Llc

    Medicine pages: Lidocaine

64. May 12, 2026 · Class II · Ongoing · D-0548-2026

    Subpotent Drug

    fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3650 Victorie St N, Suite 900, Shoreview, MN, NDC 71139-6030-1. — IntegraDose Compounding Services LLC

65. May 12, 2026 · Class II · Ongoing · D-0543-2026

    Defective Container; packets were found to be either empty or partially full.

    Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC 70954-531-20 — ANI Pharmaceuticals, Inc.

    Medicine pages: Estradiol

66. May 11, 2026 · Class II · Ongoing · D-0542-2026

    Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

    Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. — Haleon US Holdings LLC

67. May 8, 2026 · Class II · Ongoing · D-0546-2026

    Lack of Assurance of Sterility

    cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx ONLY, Manufactured by: UCB Inc., Smyrna, GA 30080, a) NDC 50474-710-79, b) Professional sample, NDC 50474-710-80; c) 3 cartons, STARTER KIT, — UCB Biosciences Inc.

    Medicine pages: Certolizumab pegol

68. May 5, 2026 · Class II · Ongoing · D-0556-2026

    Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications

    Amlodipine and Olmesartan Medoxomil Tablets, 5mg/40mg, Rx Only, 30-count bottle, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-501-30. — Ascend Laboratories, LLC

    Medicine pages: Amlodipine and olmesartan medoxomil

69. May 4, 2026 · Class III · Ongoing · D-0539-2026

    Failed Impurities/Degradation Specifications

    Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, Made in Canada, NDC 25021-241-10. — Sagent Pharmaceuticals

    Medicine pages: Busulfan

70. May 1, 2026 · Class II · Ongoing · D-0549-2026

    Presence of a Foreign Substance; black particles observed in liquid

    Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contains: Folic Acid 799 mcg/5mL, Delivers 5 mL per oral syringe, (Nephronex), Mfg By: LLORENS; Pkg by: Safecor, Columbus, OH. NDC 54859-0516-08 — Safecor Health, LLC

71. May 1, 2026 · Class III · Ongoing · D-0537-2026

    Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11 — Amerisource Health Services LLC

    Medicine pages: Primidone

72. May 1, 2026 · Class III · Ongoing · D-0536-2026

    Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11 — Amerisource Health Services LLC

    Medicine pages: Primidone

April 2026

1. April 30, 2026 · Class II · Ongoing · D-0538-2026

   Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.

   Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by: Safecor, Columbus, OH 43204. NDC: 64380-474-01 — Safecor Health, LLC

   Medicine pages: Atomoxetine

2. April 29, 2026 · Class II · Ongoing · D-0545-2026

   CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

   Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; (NDC 70710-1048-3). — Zydus Pharmaceuticals (USA) Inc

   Medicine pages: Erythromycin

3. April 29, 2026 · Class II · Ongoing · D-0544-2026

   CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit

   Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; a) 30 count bottles ( — Zydus Pharmaceuticals (USA) Inc

   Medicine pages: Erythromycin

4. April 29, 2026 · Class II · Ongoing · D-0516-2026

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06. — Ajanta Pharma Ltd.

   Medicine pages: Duloxetine

5. April 29, 2026 · Class II · Ongoing · D-0515-2026

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03 — Ajanta Pharma Ltd.

   Medicine pages: Duloxetine

6. April 29, 2026 · Class II · Ongoing · D-0514-2026

   CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.

   Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Mad — Ajanta Pharma Ltd.

   Medicine pages: Duloxetine

7. April 28, 2026 · Class I · Ongoing · D-0540-2026

   Presence of Particulate Matter.

   Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07. — B BRAUN MEDICAL INC

   Medicine pages: Sodium chloride, sodium lactate, potassium chloride, and calcium chloride

8. April 27, 2026 · Class II · Ongoing · D-0547-2026

   Failed Dissolution Specifications

   Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590 — Ascend Laboratories, LLC

   Medicine pages: Metoprolol

9. April 27, 2026 · Class III · Ongoing · D-0535-2026

   Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

   Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01 — Golden State Medical Supply Inc.

   Medicine pages: Primidone

10. April 27, 2026 · Class III · Ongoing · D-0534-2026

    Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05 — Golden State Medical Supply Inc.

    Medicine pages: Primidone

11. April 27, 2026 · Class II · Ongoing · D-0525-2026

    Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.

    Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, Sterile, Manufactured for: OASIS Medical, Inc., 514 S. Vermont Ave., Glendora, CA 91741, USA, Made in France, NDC 42126-6400-1. — Oasis Medical, Inc.

12. April 24, 2026 · Class I · Ongoing · D-0553-2026

    Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.

    MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NET WT 6 oz (170 g), Manufactured by: Pharmacal 1 Pharmacal Way, P.O. Box 198, Jackson, WI 53037. — Wisconsin Pharmacal Company

13. April 24, 2026 · Class II · Ongoing · D-0541-2026

    Presence of particulate matter: a white thread-like structure in the cartridge

    Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70 — Lupin Pharmaceuticals Inc.

    Medicine pages: Liraglutide

14. April 24, 2026 · Class III · Ongoing · D-0533-2026

    Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

    Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. — Lannett Company Inc.

    Medicine pages: Primidone

15. April 24, 2026 · Class II · Ongoing · D-0519-2026

    Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

    Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one — Teva Pharmaceuticals USA, Inc

16. April 23, 2026 · Class II · Ongoing · D-0520-2026

    Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test

    Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pha — JB Chemicals and Pharmaceuticals Ltd

    Medicine pages: Enalapril maleate

17. April 23, 2026 · Class II · Ongoing · D-0501-2026

    Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

    Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11 — Thea Pharma, Inc.

18. April 23, 2026 · Class II · Ongoing · D-0500-2026

    Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

    iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11 — Thea Pharma, Inc.

19. April 22, 2026 · Class II · Ongoing · D-0518-2026

    Lack of assurance of Sterility: potential product contamination

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becto — CareFusion 213, LLC

20. April 22, 2026 · Class II · Ongoing · D-0517-2026

    Lack of assurance of Sterility: potential product contamination

    BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42. — CareFusion 213, LLC

21. April 21, 2026 · Class II · Ongoing · D-0522-2026

    CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit

    Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, N — Breckenridge Pharmaceutical, Inc.

    Medicine pages: Duloxetine

22. April 21, 2026 · Class II · Ongoing · D-0492-2026

    Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

    GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01. — Alcon Research LLC

23. April 21, 2026 · Class II · Ongoing · D-0491-2026

    Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

    Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01 — Alcon Research LLC

24. April 20, 2026 · Class II · Ongoing · D-0523-2026

    Chemical contamination; presence of lead and lithium above specification

    NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16 — Acella Pharmaceuticals, LLC

    Medicine pages: Naproxen

25. April 20, 2026 · Class II · Ongoing · D-0499-2026

    Lack of Assurance of Sterility

    Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, Manufactured for Scope Health Inc., 79 Madison Ave., 8th Floor, New York, NY 10016, USA, NDC 72972-002-01. — SCOPE HEALTH

26. April 17, 2026 · Class II · Ongoing · D-0489-2026

    Lack of Assurance of Sterility

    FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashville, TN USA. — Harrow Eye LLC

27. April 16, 2026 · Class III · Ongoing · D-0494-2026

    Labeling: Missing Label

    Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For intravenous use, Rx Only, American Regent, Inc., Shirley, NY 11967. NDC: 0517-1045-01 — American Regent, Inc.

    Medicine pages: Levocarnitine

28. April 14, 2026 · Class III · Ongoing · D-0490-2026

    Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.

    Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08. — Premier Dental Products Co

29. April 13, 2026 · Class III · Ongoing · D-0511-2026

    Subpotent drug

    busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. Ea — Unichem Pharmaceuticals USA Inc.

    Medicine pages: Buspirone

30. April 9, 2026 · Class II · Ongoing · D-0493-2026

    Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

    Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06 — The Harvard Drug Group LLC

    Medicine pages: OMEGA-3-ACID ethyl esters

31. April 8, 2026 · Class II · Ongoing · D-0699-2026

    CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

    Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; — Blaine Labs Inc

32. April 8, 2026 · Class II · Ongoing · D-0698-2026

    CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1 — Blaine Labs Inc

33. April 8, 2026 · Class II · Ongoing · D-0697-2026

    CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

    TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 — Blaine Labs Inc

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).