Cipla USA Inc.

• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 2 products
• CapecitabineXeloda · 2 products
• NabumetoneRelafen Ds · 2 products
• Alendronate sodiumBinosto, Fosamax · 2 products
• Dimethyl fumarateTecfidera · 2 products
• FilgrastimNivestym, Releuko, Neupogen · 2 products
• TicagrelorBrilinta · 2 products
• DarunavirPrezista · 2 products
• AmbrisentanLetairis · 2 products
• EntecavirBaraclude · 2 products
• Darifenacin2 products
• CyclophosphamideFrindovyx · 2 products
• Isoproterenol hydrochloride2 products
• Terbinafine hydrochloride2 products
• LiraglutideVictoza, Saxenda · 2 products
• Sevelamer carbonateRenvela · 2 products
• Fosinopril sodium and hydrochlorothiazide2 products
• MeloxicamZybic, Xifyrm, Qamzova · 2 products
• ZolmitriptanZolmitriptan Od, Zolmiptriptan, Zomig · 2 products
• PrucaloprideMotegrity · 2 products
• NintedanibOfev · 2 products
• Omeprazole and sodium bicarbonateZegerid · 2 products
• Meprobamate2 products
• NicardipineCardene IV · 2 products
• Ipratropium bromide and albuterol sulfateCombivent Respimat · 2 products
• Emtricitabine and tenofovir disoproxil fumarateTruvada · 2 products
• DapagliflozinFarxiga · 2 products
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
• DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 1 product
• FosfomycinContepo · 1 product
• PlazomicinZemdri (Plazomicin) · 1 product
• EmtricitabineEmtriva · 1 product
• GemfibrozilLopid · 1 product
• Trospium chloride1 product
• Calcium acetate1 product
• Oseltamivir phosphateTamiflu · 1 product
• Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 1 product
• Efavirenz1 product
• Calcitonin salmonMiacalcin · 1 product
• ExemestaneAromasin · 1 product
• TestosteroneVogelxo, Natesto Nasal Gel, Testopel · 1 product
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
• Metaxalone1 product
• Arformoterol tartrate1 product
• Efavirenz, emtricitabine and tenofovir disoproxil fumarate1 product
• IcatibantSajazir, Firazyr · 1 product
• Raloxifene hydrochlorideEvista · 1 product
• GriseofulvinUltramicrosize Griseofulvin, Griseofulvin Microsize · 1 product
• Dihydroergotamine mesylateBrekiya, Trudhesa, Atzumi · 1 product
• Tenofovir disoproxil fumarateViread · 1 product
• RitonavirNorvir · 1 product
• Alfuzosin hydrochlorideUroxatral · 1 product
• ZonisamideZonegran, Zonisade · 1 product
• Abacavir and lamivudine1 product
• PaclitaxelPaclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), Paclitaxel 100mg Per Vial, Abraxane · 1 product
• AbacavirZiagen · 1 product
• Palonosetron hydrochloridePosfrea · 1 product
• TadalafilCialis, Tadliq, Adcirca · 1 product
• VigabatrinSabril, Vigadrone, Vigafyde · 1 product
• HydrocortisoneSolu-Cortef, Proctozone-Hc, Alkindi Sprinkle · 1 product
• SumatriptanImitrex, Tosymra, Zembrace Symtouch · 1 product

2026

1. February 18, 2026 · Class III · Ongoing · D-0381-2026 · Nilotinib

   Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

   Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carto

2. January 2, 2026 · Class II · Ongoing · D-0290-2026 · Lanreotide acetate

   Presence of Particulate Matter.

   Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep subcutaneous injection, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-870-67

2025

1. November 14, 2025 · Class II · Ongoing · D-0226-2026 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-412-02

2. November 14, 2025 · Class II · Ongoing · D-0225-2026 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02

3. November 14, 2025 · Class II · Ongoing · D-0224-2026 · Cinacalcet

   CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

   Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-410-02

4. October 31, 2025 · Class II · Ongoing · D-0197-2026 · Phytonadione

   Failed Stability Specifications: Observed OOS results: eg results for colour index

   Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097

5. October 24, 2025 · Class II · Ongoing · D-0217-2026 · Lanthanum carbonate

   Failed stability specifications: Out of specification for hardness test

   Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boule

6. July 24, 2025 · Class III · Ongoing · D-0593-2025 · Albuterol sulfate

   Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

   Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300

7. June 30, 2025 · Class II · Ongoing · D-0541-2025 · Budesonide

   Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

   Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Bouleva

2024

1. March 26, 2024 · Class II · Terminated · D-0471-2024 · Ipratropium bromide and albuterol sulfate

   Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

   Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ

2023

1. November 17, 2023 · Class I · Completed · D-0220-2024 · Vigabatrin

   Defective Container: powder may leak out of the pouch

   Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., War

2. June 27, 2023 · Class I · Terminated · D-0938-2023 · Albuterol sulfate

   Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

   Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 1

2022

1. September 29, 2022 · Class II · Terminated · D-1550-2022 · Arformoterol tartrate

   Lack of Assurance of Sterility: environmental monitoring failure.

   Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 6909

2. September 15, 2022 · Class II · Terminated · D-1545-2022 · Budesonide

   Lack of Assurance of Sterility

   Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension, Manufactured by: Cipla Ltd., India, Manufactured for Cipla USA Inc., Wa

3. August 22, 2022 · Class II · Terminated · D-1499-2022 · Difluprednate

   Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

   Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

4. August 2, 2022 · Class II · Terminated · D-1328-2022 · Difluprednate

   Lack of Assurance of Sterility: Complaints received of defective container closure.

   Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

5. July 14, 2022 · Class II · Terminated · D-1283-2022 · Difluprednate

   Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

   Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 I

6. January 26, 2022 · Class II · Terminated · D-0190-2024 · Meloxicam

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Meloxicam Tablets, USP, 15 mg, 1000 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., Kurkumbh, India; Manufactured for: Cipla USA, Inc., 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156. NDC: 69097-159-15

7. January 26, 2022 · Class II · Terminated · D-0161-2024 · Ipratropium bromide and albuterol sulfate

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203;

2021

1. March 15, 2021 · Class II · Terminated · D-0463-2021 · Meloxicam

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156

2. March 15, 2021 · Class II · Terminated · D-0464-2021 · Nadolol

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156

2020

1. December 17, 2020 · Class II · Terminated · D-0183-2021 · Esomeprazole

   Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

   Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30

2. December 17, 2020 · Class II · Terminated · D-0181-2021 · Esomeprazole

   Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

   Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30

3. December 17, 2020 · Class II · Terminated · D-0182-2021 · Esomeprazole

   Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

   Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 30

2019

1. June 12, 2019 · Class III · Terminated · D-1454-2019 · Testosterone

   Defective Container; actuator may improperly function and affect dose delivery.

   Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: C

2. March 22, 2019 · Class II · Terminated · D-1125-2019 · Testosterone cypionate

   Presence of Particulate Matter.

   Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw

3. March 22, 2019 · Class II · Terminated · D-1123-2019 · Testosterone cypionate

   Presence of Particulate Matter.

   Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw

4. March 22, 2019 · Class II · Terminated · D-1124-2019 · Testosterone cypionate

   Presence of Particulate Matter.

   Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite

2018

1. October 3, 2018 · Class III · Terminated · D-0012-2019 · Amlodipine

   Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

   Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097

2. September 6, 2018 · Class III · Terminated · D-1212-2018 · Bupropion

   Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.

   Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68

3. March 15, 2018 · Class III · Terminated · D-0618-2018 · Bupropion

   Failed Dissolution Specifications; during stability testing

   buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals,

4. March 15, 2018 · Class III · Terminated · D-0619-2018 · Bupropion

   Failed Dissolution Specifications; during stability testing

   buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Su

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).