Lupin Pharmaceuticals, Inc.

• LevothyroxineTirosint, Tirosint Sol, Synthroid · 12 products
• DoxycyclineDoxy 100, Acticlate Cap, Doryx Mpc · 11 products
• QuetiapineSeroquel, Seroquel XR · 11 products
• FenofibrateAntara, Lipofen, Tricor · 10 products
• Amlodipine besylate and benazepril hydrochloride10 products
• LisinoprilZestril, Qbrelis · 10 products
• Losartan potassiumLosortan Potassium, Cozaar, Arbli · 9 products
• Amlodipine and valsartanExforge · 8 products
• MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 8 products
• Imipramine7 products
• Potassium chlorideKlor-Con, Klor-Con M, Pokonza · 6 products
• Memantine hydrochloride6 products
• Tramadol hydrochlorideConzip · 6 products
• DasatinibSprycel, Phyrago · 6 products
• Hydrocodone bitartrate and acetaminophenNorco · 6 products
• Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 6 products
• LevetiracetamKeppra, Spritam, Keppra XR · 6 products
• Sertraline hydrochlorideZoloft · 6 products
• Morphine sulfateMs Contin, Mitigo, Duramorph · 5 products
• Valsartan and hydrochlorothiazideDiovan Hct · 5 products
• Cefprozil5 products
• Lurasidone hydrochlorideLatuda · 5 products
• Amlodipine besylate valsartan hydrochlorothiazideExforge Hct · 5 products
• DesoximetasoneTopicort · 5 products
• SimvastatinZocor · 5 products
• Divalproex sodiumDepakote, Depakote ER, Depakote Sprinkles · 5 products
• Zolpidem tartrateAmbien, Ambien CR, Edluar · 4 products
• Metformin hydrochlorideGlumetza · 4 products
• Pravastatin sodium4 products
• AtorvastatinLipitor · 4 products
• TopiramateTopamax, Qudexy XR, Trokendi XR · 4 products
• Eslicarbazepine acetateAptiom · 4 products
• Quinapril4 products
• Ramipril4 products
• Oseltamivir phosphateTamiflu · 4 products
• Clobetasol propionateClobetasol Propionate (Emollient), Byqlovi, Tovet (Emollient Formulation) · 4 products
• Oxycodone and acetaminophenEndocet, Prolate, Percocet · 4 products
• Minocycline hydrochlorideArestin, Zilxi, Amzeeq · 4 products
• DuloxetineDrizalma Sprinkle · 4 products
• Cephalexin4 products
• Dapagliflozin and metformin hydrochlorideXigduo XR · 4 products
• CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
• MeloxicamZybic, Xifyrm, Qamzova · 4 products
• Quinapril HCL and hydrochlorothiazide3 products
• Cefadroxil3 products
• Losartan potassium and hydrochlorothiazideHyzaar · 3 products
• Lovastatin3 products
• Lisinopril and hydrochlorothiazideZestoretic · 3 products
• Trandolapril3 products
• DesvenlafaxinePristiq Extended-Release · 3 products
• DroxidopaNorthera · 3 products
• FluoxetineProzac · 3 products
• Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 3 products
• Telmisartan and hydrochlorothiazideMicardis Hct · 3 products
• Cefixime3 products
• VoriconazoleVfend · 3 products
• AzithromycinZithromax, Azasite · 3 products
• AmlodipineNorvasc, Sdamlo, Norliqva · 3 products
• EszopicloneLunesta · 3 products
• ParoxetinePaxil, Paxil CR, Brisdelle · 3 products
• Cefdinir3 products
• RufinamideBanzel · 3 products
• Lanthanum carbonateFosrenol · 3 products
• BromfenacBromsite 0.075%, Prolensa · 3 products
• Sacubitril and valsartanEntresto · 3 products
• Nitrofurantoin3 products
• Clomipramine hydrochlorideAnafranil · 3 products
• Levofloxacin3 products
• Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloridePeg-3350 and Electrolytes, Golytely, PEG 3350 and Electrolytes · 2 products
• DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 2 products
• NabumetoneRelafen Ds · 2 products
• Ethambutol hydrochloride2 products
• PitolisantWakix · 2 products
• TinidazoleTindazole, Tindamax · 2 products
• FlucytosineAncobon · 2 products
• Fenofibric acid (choline fenofibrate)2 products
• MirabegronMyrbetriq, Mirabgeorn · 2 products
• DarunavirPrezista · 2 products
• MoxifloxacinVigamox · 2 products
• Varenicline tartrateChantix, Tyrvaya · 2 products
• MisoprostolCytotec · 2 products
• FamotidinePepcid · 2 products
• MetoclopramideReglan, Gimoti · 2 products
• RanolazineAspruzyo Sprinkle · 2 products
• Norethindrone acetate and ethinyl estradiolJunel 21 Day, Loestrin 21 Day, Fyavolv · 2 products
• LeflunomideArava · 2 products
• Ipratropium bromideAtrovent HFA · 2 products
• SugammadexBridion · 2 products
• PrucaloprideMotegrity · 2 products
• TestosteroneVogelxo, Natesto Nasal Gel, Testopel · 2 products
• Azilsartan kamedoxomilAzilsartan Medoxomil, Edarbi · 2 products
• TolvaptanJynarque, Samsca · 2 products
• DiclofenacZipsor, Lofena, Cambia · 2 products
• ClobazamSympazan, Onfi · 2 products
• Telmisartan and amlodipine2 products
• BupropionWellbutrin SR, Aplenzin, Wellbutrin XL · 2 products
• Silodosin2 products
• Doxorubicin hydrochlorideDoxil, Doxorubicin Hydrochloride Liposome · 2 products
• DiazepamValium, Valtoco · 2 products
• IrbesartanAvapro · 2 products
• DapagliflozinFarxiga · 2 products
• RivaroxabanXarelto · 2 products
• NorethindroneErrin, Nora Be, Camila · 2 products
• Rifampin2 products
• Phenelzine sulfateNardil · 1 product
• Betamethasone dipropionateDiprolene, Sernivo · 1 product
• TiotropiumSpiriva Handihaler, Spiriva Respimat · 1 product
• PenicillamineAagylur, Depen, Cuprimine · 1 product
• AtovaquoneMepron · 1 product
• LiraglutideVictoza, Saxenda · 1 product
• Methylergonovine maleateMethergine · 1 product
• Trimethoprim1 product
• Pentazocine hydrochloride and naloxone hydrochloride1 product
• Cevimeline hydrochlorideEvoxac · 1 product
• SildenafilViagra, Vybrique, Revatio · 1 product
• Ganirelix acetateFyremadel · 1 product
• Glycerol phenylbutyrateRavicti · 1 product
• Ethacrynic acidEdecrin · 1 product
• Donepezil hydrochlorideAricept · 1 product
• Nystatin and triamcinolone acetonide1 product
• Arformoterol tartrate1 product
• PosaconazoleNoxafil · 1 product
• Formoterol fumaratePerforomist · 1 product
• LapatinibTykerb · 1 product
• Orphenadrine citrate1 product
• DesloratadineClarinex · 1 product
• Mefenamic acid1 product
• Abacavir , lamivudine and zidovudine1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 1 product
• BumetanideBumex, Enbumyst · 1 product
• LevalbuterolXopenex HFA · 1 product
• Fluocinolone acetonideFluocinolone Acetonide Oil, Derma-Smoothe/Fs, Synalar · 1 product
• Hydrocodone bitartrate and homatropine methylbromide1 product
• CyanocobalaminNascobal · 1 product
• Trimethobenzamide hydrochlorideTigan · 1 product
• Sodium sulfate, potassium sulfate, magnesium sulfateSuprep Bowel Prep, Sodium Sulfate, Potassium Sulfate, and Magnesium Sulfate Bowel Prep Kit · 1 product
• CarbidopaLodosyn · 1 product
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 1 product
• NiacinNiacor · 1 product
• Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
• Abacavir and lamivudine1 product
• TadalafilCialis, Tadliq, Adcirca · 1 product
• Hydrocortisone valerate1 product
• Sevelamer hydrochloride1 product
• EscitalopramLexapro · 1 product
• ValsartanDiovan · 1 product
• Pegfilgrastim-cbqvUdenyca, Stimufend, Neulasta · 1 product
• Loteprednol etabonateLotemax, Lotemax Sm, Alrex · 1 product
• LinezolidZyvox · 1 product
• Fluocinonide1 product
• Polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloridePEG 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride, Trilyte, Peg-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride · 1 product
• BosentanTracleer · 1 product
• ClonidineClonidine Transdermal System, Catapres-Tts-1, Clonidine Transdermal System Usp, 0.1 Mg/Day · 1 product
• Hydrocortisone butyrateEvesse · 1 product
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
• RaltegravirIsentress · 1 product
• BrivaracetamBriviact · 1 product
• Sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrousSodium Phosphates · 1 product
• Quinine sulfate1 product
• LamivudineEpivir · 1 product
• Prednisolone acetatePred Forte, Pred Mild · 1 product

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.
• BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.

The sponsor is the company that holds the FDA application; it can differ from the labeler.

2026

1. August 3, 2026 · Class II · Ongoing · D-0789-2026 · Clobetasol propionate

   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.

2. June 4, 2026 · Class II · Ongoing · D-0655-2026 · Prednisolone acetate

   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

3. April 24, 2026 · Class II · Ongoing · D-0541-2026 · Liraglutide

   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

2025

1. November 13, 2025 · Class II · Ongoing · D-0220-2026 · Ganirelix acetate

   Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.

   Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin

2. November 5, 2025 · Class II · Ongoing · D-0227-2026 · Sertraline hydrochloride

   Defective container - seal not adhering to bottles

   Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

3. July 2, 2025 · Class II · Terminated · D-0542-2025 · Amlodipine besylate and benazepril hydrochloride

   Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

   Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA,

4. June 27, 2025 · Class II · Terminated · D-0537-2025 · Clomipramine hydrochloride

   Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

   clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

5. June 20, 2025 · Class II · Ongoing · D-0532-2025 · Lisinopril and hydrochlorothiazide

   Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

   Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01

6. April 10, 2025 · Class II · Terminated · D-0377-2025 · Clomipramine hydrochloride

   Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

   clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 681

2024

1. December 20, 2024 · Class II · Terminated · D-0167-2025 · Levothyroxine

   Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

   Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 77

2. October 23, 2024 · Class II · Terminated · D-0053-2025 · Ramipril

   CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

   Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured

3. October 23, 2024 · Class II · Terminated · D-0054-2025 · Ramipril

   CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

   Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured

4. October 23, 2024 · Class II · Terminated · D-0052-2025 · Ramipril

   CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

   Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufacture

5. August 21, 2024 · Class II · Terminated · D-0648-2024 · Cefixime

   Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

   Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

6. May 30, 2024 · Class II · Terminated · D-0559-2024 · Cefixime

   Failed Content Uniformity Specifications

   Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited, Mandideep, India NDC

7. May 8, 2024 · Class II · Terminated · D-0518-2024 · Cefdinir

   Defective container: lack of seal integrity.

   Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 046 India, NDC 68180-

8. April 24, 2024 · Class II · Terminated · D-0497-2024 · Cefdinir

   Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

   Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man

9. April 24, 2024 · Class II · Terminated · D-0496-2024 · Cefdinir

   Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.

   Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Man

10. February 5, 2024 · Class II · Terminated · D-0337-2024 · Voriconazole

    Labeling: Incorrect or Missing Package Insert

    Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufac

11. January 5, 2024 · Class II · Terminated · D-0283-2024 · Rifampin

    Subpotent Drug and Failed Impurities/Degradation Specifications

    Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06

12. January 5, 2024 · Class II · Terminated · D-0284-2024 · Rifampin

    Subpotent Drug and Failed Impurities/Degradation Specifications

    Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06

13. January 3, 2024 · Class II · Terminated · D-0274-2024 · Cefixime

    Failed Impurities/Degradation Specifications

    Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

2023

1. December 20, 2023 · Class II · Terminated · D-0221-2024 · Desloratadine

   CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

   Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.

2. November 22, 2023 · Class II · Terminated · D-0148-2024 · Penicillamine

   Failed Dissolution Specifications

   Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

3. June 27, 2023 · Class III · Terminated · D-0899-2023 · Amlodipine

   Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.

   Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03

4. January 20, 2023 · Class III · Terminated · D-0174-2023 · Clobetasol propionate

   Subpotent Drug: Low assay result observed during long-term stability testing.

   Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-956-03

2022

1. December 12, 2022 · Class II · Terminated · D-0100-2023 · Rifampin

   Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

   Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

2. December 7, 2022 · Class II · Terminated · D-0089-2023 · Quinapril

   CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

   Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

3. December 7, 2022 · Class II · Terminated · D-0088-2023 · Quinapril

   CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

   Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

4. September 13, 2022 · Class II · Terminated · D-1536-2022 · Lisinopril

   Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

   Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03

5. July 28, 2022 · Class II · Terminated · D-1343-2022 · Rifampin

   CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.

   Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06

6. April 27, 2022 · Class II · Terminated · D-0875-2022 · Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride

   Failed Stability Specification

   GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

7. March 31, 2022 · Class II · Terminated · D-0840-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc.

8. March 31, 2022 · Class II · Terminated · D-0838-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. B

9. March 31, 2022 · Class II · Terminated · D-0839-2022 · Losartan potassium

   CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

   Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. B

10. March 31, 2022 · Class II · Terminated · D-0841-2022 · Losartan potassium and hydrochlorothiazide

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: L

11. March 31, 2022 · Class II · Terminated · D-0843-2022 · Losartan potassium and hydrochlorothiazide

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For:

12. March 31, 2022 · Class II · Terminated · D-0842-2022 · Losartan potassium and hydrochlorothiazide

    CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

    Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lu

13. January 26, 2022 · Class II · Terminated · D-0178-2024 · Doxycycline

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

    Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08

14. January 26, 2022 · Class II · Terminated · D-0163-2024 · Albuterol sulfate

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

    ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 4

15. January 26, 2022 · Class II · Terminated · D-0188-2024 · Lisinopril and hydrochlorothiazide

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

    Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, Ind

2021

1. December 29, 2021 · Class III · Terminated · D-0358-2022 · Oxycodone hydrochloride

   Out-of-specification impurity test result observed at 18-month long term stability time point.

   Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-

2. October 12, 2021 · Class II · Terminated · D-0086-2022 · Irbesartan

   CGMP Deviations: impurity N-nitrosoirbesartan detected in API

   Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

3. October 12, 2021 · Class II · Terminated · D-0087-2022 · Irbesartan

   CGMP Deviations: impurity N-nitrosoirbesartan detected in API

   Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

4. October 12, 2021 · Class II · Terminated · D-0088-2022 · Irbesartan

   CGMP Deviations: impurity N-nitrosoirbesartan detected in API

   Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

5. October 8, 2021 · Class II · Terminated · D-0027-2022 · Imipramine

   Out of specification result observed in a dissolution test at the 9-month long term stability time point.

   Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 681

6. July 29, 2021 · Class II · Terminated · D-0726-2021 · Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride

   Failed Stability Specification; Out of specification for Osmolarity

   GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 ND

7. April 29, 2021 · Class II · Terminated · D-0390-2021 · Cefixime

   Subpotent Drug

   Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, ND

8. March 26, 2021 · Class II · Terminated · D-0332-2021 · Cefprozil

   Superpotent Drug

   Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68180-402-03); Rx only

9. January 21, 2021 · Class III · Terminated · D-0247-2021 · Oseltamivir phosphate

   Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.

   Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Ma

2020

1. July 7, 2020 · Class II · Terminated · D-1382-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   Metformin Hydrochloride Extended-release Tablets USP 500 mg, 100 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-338-01

2. July 7, 2020 · Class II · Terminated · D-1385-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-337-07

3. July 7, 2020 · Class II · Terminated · D-1383-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   Metformin Hydrochloride Extended-Release Tablets USP 1000 mg, 90 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-339-09

4. July 7, 2020 · Class II · Terminated · D-1384-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   Metformin Hydrochloride Extended-Release Tablets USP 500 mg, 60 count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Manufactured by: Lupin Limited, Goa INDIA NDC 68180-336-07

5. July 2, 2020 · Class II · Terminated · D-1406-2020 · Cefdinir

   Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.

   Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India, NDC 68180-723-20

6. June 11, 2020 · Class II · Terminated · D-1334-2020 · Metformin hydrochloride

   CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

   Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)

7. May 28, 2020 · Class II · Terminated · D-1290-2020 · Lisinopril

   Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

   Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

8. April 15, 2020 · Class II · Terminated · D-1252-2020 · Cefixime

   Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

   Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

9. April 1, 2020 · Class II · Terminated · D-1079-2020 · Lisinopril

   Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

   Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

10. February 12, 2020 · Class II · Terminated · D-0855-2020 · Memantine hydrochloride

    Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

    Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-

Showing the newest 60 of 108.

What do the recall classes mean?

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).

1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026

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