Teva Pharmaceuticals USA, Inc.

• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 14 products
• Warfarin sodiumJantoven · 9 products
• AmoxicillinAmoxil · 9 products
• ClonazepamKlonopin · 8 products
• Venlafaxine hydrochlorideEffexor XR · 8 products
• Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 8 products
• Glyburide8 products
• AtomoxetineStrattera, Atoncy · 7 products
• RisperidoneUzedy, Risperdal, Risperdal M-Tab · 7 products
• Ustekinumab-aeknSelarsdi · 7 products
• Fluticasone propionate and salmeterolFluticasone Propionate and Salmeterol Diskus, Advair Diskus, Advair HFA · 6 products
• Cephalexin6 products
• QuetiapineSeroquel, Seroquel XR · 6 products
• Hydroxyzine6 products
• Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)Augmentin Es-600, Augmentin · 5 products
• EstradiolEstradiol Vaginal, Dotti, Estradiol Transdermal System · 5 products
• Cyclobenzaprine hydrochlorideAmrix, Tonmya, Fexmid · 5 products
• ClozapineClozaril, Versacloz · 5 products
• Olanzapine and fluoxetine5 products
• BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 5 products
• Olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideTribenzor · 5 products
• BudesonidePulmicort Flexhaler, Pulmicort Respules, Uceris · 5 products
• Nefazodone hydrochloride5 products
• AzithromycinZithromax, Azasite · 5 products
• Nortriptyline hydrochloridePamelor · 4 products
• Sotalol hydrochlorideBetapace, Sotalol Hydrochloride Af, Betapace Af · 4 products
• Penicillin v potassium4 products
• DoxazosinCardura, Cardura XL · 4 products
• OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 4 products
• Tiagabine hydrochloride4 products
• Sunitinib malateSutent · 4 products
• CyclosporineSandimmune, Neoral, Cyclosporine Modified · 4 products
• Hydralazine hydrochloride4 products
• IsotretinoinZenatane, Absorica, Accutane · 4 products
• CarvedilolCoreg, Coreg CR · 4 products
• TorsemideSoaanz · 4 products
• BuspironeBucapsol · 4 products
• AtorvastatinLipitor · 4 products
• Tolterodine tartrateDetrol · 4 products
• DiltiazemTiadylt ER, Cartia Xt, Tiazac Extended Release · 4 products
• LansoprazolePrevacid Solutab, Prevacid · 4 products
• Vardenafil4 products
• Trazodone hydrochlorideRaldesy Tm · 4 products
• Norethindrone acetate and ethinyl estradiolJunel 21 Day, Loestrin 21 Day, Fyavolv · 3 products
• Lovastatin3 products
• Acitretin3 products
• Liothyronine sodiumCytomel, Liomny · 3 products
• Cefdinir3 products
• LorazepamAtivan, Loreev XR · 3 products
• AtazanavirReyataz · 3 products
• EszopicloneLunesta · 3 products
• Famciclovir3 products
• Mexiletine hydrochloride3 products
• Danazol3 products
• Medroxyprogesterone acetateProvera, Depo-Provera, Depo-Subq Provera · 3 products
• ArmodafinilNuvigil · 3 products
• Bisoprolol fumarate and hydrochlorothiazide3 products
• LevalbuterolXopenex HFA · 3 products
• FluoxetineProzac · 3 products
• Losartan potassium and hydrochlorothiazideHyzaar · 3 products
• FluvastatinLescol XL · 3 products
• Glipizide and metformin hydrochloride3 products
• Erlotinib3 products
• Cimetidine3 products
• AtenololTenormin · 3 products
• HydrochlorothiazideInzirqo · 3 products
• SildenafilViagra, Vybrique, Revatio · 3 products
• Etodolac3 products
• PioglitazoneActos · 3 products
• DiazepamValium, Valtoco · 3 products
• Prazosin hydrochloride3 products
• Lanthanum carbonateFosrenol · 3 products
• Carbidopa and levodopaCrexont, Rytary, Sinemet · 3 products
• Fluocinonide3 products
• Risedronate3 products
• Chlordiazepoxide hydrochloride3 products
• Leucovorin calciumVykoura · 2 products
• CapecitabineXeloda · 2 products
• Eletriptan hydrobromideRelpax · 2 products
• Isoniazid2 products
• Megestrol acetate2 products
• DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 2 products
• Moexipril hydrochloride2 products
• Cefprozil2 products
• RasagilineAzilect · 2 products
• BaclofenGablofen, Lyvispah, Baclofen (Intrathecal) · 2 products
• Cilostazol2 products
• Cefadroxil2 products
• Almotriptan2 products
• MetronidazoleMetronidazole Vaginal, Metronidazole Vaginal Gel, Likmez · 2 products
• Fremanezumab-vfrmAjovy · 2 products
• Piroxicam2 products
• Isradipine2 products
• Dicloxacillin sodium2 products
• ErythromycinEry, Ery-Tab · 2 products
• EpinephrineAuvi-Q, Adrenalin, Adrenalin (Epinephrine in Sodium Chloride) · 2 products
• Disopyramide phosphateNorpace · 2 products
• Irbesartan and hydrochlorothiazideAvalide · 2 products
• MesalaminePentasa, Lialda, Mesalamine Rectal · 2 products
• FamotidinePepcid · 2 products
• MetoclopramideReglan, Gimoti · 2 products
• CalcitriolVectical · 2 products
• Imatinib mesylateGleevec, Imkeldi · 2 products
• Rizatriptan benzoateRizafilm, Maxalt-Mlt, Maxalt · 2 products
• NystatinNystop, Klayesta, Nyamyc · 1 product
• Cefaclor1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• Norethindrone acetateGallifrey · 1 product
• MethotrexateRasuvo, Otrexup, Trexall · 1 product
• SucralfateCarafate · 1 product
• PenciclovirDenavir · 1 product
• Efavirenz, emtricitabine and tenofovir disoproxil fumarate1 product
• Mycophenolate mofetilCellcept, Myhibbin · 1 product
• LetrozoleFemara · 1 product
• Levocetirizine dihydrochlorideXyzal · 1 product
• Oseltamivir phosphateTamiflu · 1 product
• Doxepin hydrochlorideSilenor, Prudoxin, Zonalon · 1 product
• Quinine sulfate1 product
• IcatibantSajazir, Firazyr · 1 product
• Estradiol and norethindrone acetateLopreeza, Combipatch (Estradiol/Norethindrone Acetate Transdermal System), Etyqa · 1 product
• TioproninThiola Ec, Venxxiva, Thiola · 1 product
• Cromolyn sodiumGastrocrom · 1 product
• ImiquimodZyclara · 1 product
• KetoconazoleKetodan · 1 product
• Raloxifene hydrochlorideEvista · 1 product
• ClopidogrelPlavix · 1 product
• Etonogestrel and ethinyl estradiolNuvaring, Enilloring, Eluryng · 1 product
• HydroxyureaDroxia, Hydrea, Siklos · 1 product
• DiazoxideProglycem · 1 product
• Methylergonovine maleateMethergine · 1 product
• Pravastatin sodium1 product
• Eculizumab-aaghEpysqli, Soliris, Bkemv · 1 product
• Neomycin sulfate1 product
• Formoterol fumaratePerforomist · 1 product
• Cabergoline1 product
• AnastrozoleArimidex · 1 product
• Bendamustine hydrochlorideTreanda, Vivimusta, Belrapzo · 1 product
• MupirocinPirnuo · 1 product
• Teriparatide (teriparatide acetate)1 product
• AcyclovirZovirax, Avaclyr · 1 product
• Emtricitabine and tenofovir disoproxil fumarateTruvada · 1 product
• LiraglutideVictoza, Saxenda · 1 product
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
• DiclofenacZipsor, Lofena, Cambia · 1 product
• CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 1 product
• Hydroxychloroquine sulfatePlaquenil, Sovuna · 1 product
• SulfasalazineAzulfidine, Azulfidine En-Tabs · 1 product
• Tramadol hydrochlorideConzip · 1 product
• OxybutyninOxytrol · 1 product
• Amiloride hydrochloride and hydrochlorothiazide1 product
• Loperamide hydrochloride1 product
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
• Mefloquine hydrochloride1 product
• Diclofenac epolamineLicart, Flector, Diclox Patch 30ct · 1 product
• DiflunisalDolobid · 1 product
• Norethindrone and ethinyl estradiolNortrel 21 Day · 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. September 29, 2026 · Class II · Ongoing · D-0038-2027 · Metoclopramide

   Presence of Foreign Tablets/Capsules

   Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC 100 Tablets: 0093-2204-01; NDC 500 Tablets: 0093-2204-05

2. August 24, 2026 · Class II · Ongoing · D-0834-2026 · Trazodone hydrochloride

   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

3. April 6, 2026 · Class II · Ongoing · D-0521-2026 · Isotretinoin

   Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

   Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx

2025

1. October 7, 2025 · Class II · Ongoing · D-0104-2026 · Prazosin hydrochloride

   CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

   Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10

2. October 7, 2025 · Class II · Ongoing · D-0106-2026 · Prazosin hydrochloride

   CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

   Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-

3. October 7, 2025 · Class II · Ongoing · D-0105-2026 · Prazosin hydrochloride

   CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.

   Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10

4. June 11, 2025 · Class III · Ongoing · D-0527-2025 · Pitavastatin

   Failed Impurities/Degradation Specifications.

   Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiw

5. June 11, 2025 · Class III · Ongoing · D-0526-2025 · Pitavastatin

   Failed Impurities/Degradation Specifications.

   Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Pharma Co., Ltd., 8 Kehu 1st Road, Huwei Chen, Yunlin, Taiwan, 63247, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054, Product of Taiw

6. May 23, 2025 · Class II · Ongoing · D-0473-2025 · Metoclopramide

   Presence of foreign tablets/capsules.

   Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Croatia, Manufactured for Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 0093-2203-01.

2024

1. January 25, 2024 · Class III · Ongoing · D-0321-2024 · Norethindrone and ethinyl estradiol

   Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

   Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454,

2023

1. July 5, 2023 · Class II · Terminated · D-0913-2023 · Sunitinib malate

   Failed Moisture Limits: Water (moisture) content above the approved product specifications.

   Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

2022

1. August 29, 2022 · Class II · Terminated · D-1539-2022 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.

   Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceut

2. August 23, 2022 · Class II · Terminated · D-1473-2022 · Neomycin sulfate

   CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

   Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01

3. April 13, 2022 · Class II · Terminated · D-1075-2022 · Mupirocin

   cGMP deviations: Temperature abuse

   Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC 0093-1010-42, MFG: Teva Pharma USA

4. January 26, 2022 · Class II · Terminated · D-0180-2024 · Estradiol

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

   ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02

5. January 26, 2022 · Class II · Terminated · D-0165-2024 · Amoxicillin

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

   AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

6. January 26, 2022 · Class II · Terminated · D-0200-2024 · Warfarin sodium

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

   Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01

7. January 26, 2022 · Class II · Terminated · D-0201-2024 · Warfarin sodium

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

   Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01

8. January 7, 2022 · Class III · Terminated · D-0522-2022 · Estradiol and norethindrone acetate

   Mislabeling

   Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc

9. January 7, 2022 · Class III · Terminated · D-0521-2022 · Estradiol and norethindrone acetate

   Mislabeling

   Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA In

2021

1. March 15, 2021 · Class II · Terminated · D-0577-2021 · Epinephrine

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27

2. March 15, 2021 · Class II · Terminated · D-0574-2021 · Neomycin sulfate

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01

3. March 15, 2021 · Class II · Terminated · D-0578-2021 · Epinephrine

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27

4. March 15, 2021 · Class II · Terminated · D-0575-2021 · Bisoprolol fumarate and hydrochlorothiazide

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS

5. March 15, 2021 · Class II · Terminated · D-0576-2021 · Penicillin v potassium

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73

2020

1. September 4, 2020 · Class II · Terminated · D-0003-2021 · Buprenorphine

   Failed Stability Specifications: Below specification result for buprenorphine release rate.

   Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva

2. August 24, 2020 · Class II · Terminated · D-1566-2020 · Cephalexin

   Sub-Potent Drug: Out of specification test results for potency (below specification).

   Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73.

3. August 24, 2020 · Class II · Terminated · D-0012-2021 · Cephalexin

   CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

   Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA,

4. August 24, 2020 · Class II · Terminated · D-0013-2021 · Cephalexin

   CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

   Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA,

5. May 22, 2020 · Class II · Terminated · D-1285-2020 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Some bottles may contain mixed strengths of the product.

   Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wa

6. May 22, 2020 · Class II · Terminated · D-1287-2020 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Some bottles may contain mixed strengths of the product.

   Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North W

7. May 22, 2020 · Class II · Terminated · D-1286-2020 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Some bottles may contain mixed strengths of the product.

   Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North W

8. March 5, 2020 · Class II · Terminated · D-1260-2020 · Epinephrine

   CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

   Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

2019

1. March 11, 2019 · Class III · Terminated · D-1006-2019 · Lansoprazole

   Subpotent Drug.

   Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufact

2018

1. September 21, 2018 · Class II · Terminated · D-0001-2019 · Clozapine

   Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

   Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed wit

2. March 19, 2018 · Class II · Terminated · D-0620-2018 · Estradiol

   Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.

   Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC 0093-3223-97), Rx only, Teva Women's Health, Inc. Subsidiary of Teva Pharmaceuticals USA, North Wale

2017

1. November 28, 2017 · Class III · Terminated · D-0108-2018 · Penicillin v potassium

   Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

   Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuti

2. July 24, 2017 · Class II · Terminated · D-1056-2017 · Famotidine

   Failed Tablet/Capsule Specification; out of specification for tablet weight

   Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60

2016

1. June 24, 2016 · Class II · Terminated · D-1470-2016 · Amoxicillin

   Superpotent drug: Out of specification test result for assay during stability testing.

   Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76

2015

1. December 21, 2015 · Class II · Terminated · D-0732-2016 · Capecitabine

   Failed Dissolution Specifications: low test results at the 18 month time-point

   Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, P

2. November 12, 2015 · Class II · Terminated · D-0566-2016 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Failed Impurities/Degradation Specifications: High out of specification test result for impurities during stability testing.

   DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets (Mixed Salts of a Single Entity Amphetamine Product), 10 mg, 100-count bottle, Rx only, Teva Pharmaceuticals

3. October 20, 2015 · Class III · Terminated · D-0521-2016 · Irbesartan and hydrochlorothiazide

   Labeling: Incorrect or Missing Lot AND/OR Exp Date.

   Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL IND

4. June 24, 2015 · Class II · Terminated · D-1283-2015 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Failed Impurities/Degradation Specifications: out of specification for unknown impurity

   Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, (CII), 10 mg (Mixed Salts of a Single Entity Amphetamine Product), 100 count bottles, manufactured at Barr L

5. April 13, 2015 · Class II · Terminated · D-0971-2015 · Fluoxetine

   Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

   Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manu

6. April 13, 2015 · Class II · Terminated · D-0970-2015 · Fluoxetine

   Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

   Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01

2014

1. October 8, 2014 · Class II · Terminated · D-0050-2015 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   Failed Impurities/Degradation Specifications: Out of specification for unknown impurities.

   DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE Tablets, (CII), 10 mg, 100 Tablet Bottles, Rx Only. Teva Pharmaceuticals USA , Sellersville, PA 18960, NDC: 0555-0972

2. May 29, 2014 · Class II · Terminated · D-1430-2014 · Fluvastatin

   Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule breakage.

   Fluvastatin Capsules USP, 20 mg, Rx Only, 30-count bottle, manufactured for Teva Pharmaceuticals, Sellersville, PA, by Teva Pharmaceutical IND LTD, Jerusalem, Israel, NDC 0093-7442-56

3. May 1, 2014 · Class II · Terminated · D-1408-2014 · Dextroamphetamine

   Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.

   Dextroamphetamine Sulfate Tablets, USP, 10 mg, 100-count bottles, Rx only, Barr Laboratories, Inc., Pomona, NY 10970, NDC 0555-0953-02.

4. February 12, 2014 · Class II · Terminated · D-1280-2014 · Fluoxetine

   Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

   Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx onl

5. February 12, 2014 · Class II · Terminated · D-1281-2014 · Fluoxetine

   Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

   Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 501

6. January 24, 2014 · Class II · Terminated · D-1093-2014 · Hydroxyzine

   CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

   Teva Hydroxyzine Pamoate Capsules, USP, 100 mg, 100- count bottle,Rx only, Distributed by Teva Pharmaceuticals USA, Sellersville, PA. NDC 0555-0324-02

7. January 24, 2014 · Class II · Terminated · D-1095-2014 · Hydroxyzine

   CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.

   Teva Hydroxyzine Pamoate Capsules, USP, 25 mg, 100- count bottle, Rx Only,Distributed by Teva Pharmaceuticals, USA, Sellersville, PA. NDC 0555-0323-02.

8. January 24, 2014 · Class II · Terminated · D-1094-2014 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

   CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.

   Teva Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg (mixed salts) , 100 count-bottle, Rx Only, Distributed by Teva Pharmaceuticals, USA, Sellersv

2013

1. June 18, 2013 · Class III · Terminated · D-803-2013 · Amoxicillin

   Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

   Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for:

2. April 26, 2013 · Class III · Terminated · D-598-2013 · Amoxicillin

   Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

   Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)

3. March 15, 2013 · Class III · Terminated · D-682-2013 · Norethindrone acetate and ethinyl estradiol

   Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

   Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

4. February 26, 2013 · Class II · Terminated · D-247-2013 · Cefdinir

   Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.

   Cefdinir for Oral Suspension, 125 mg/5 mL, packaged in a) 60 mL bottle (NDC 0093-4136-64); b) 100 mL bottle (NDC 0093-4136-73), Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960.

2012

1. April 24, 2012 · Class III · Terminated · D-128-2013 · Cabergoline

   Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life

   CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88

2. April 2, 2012 · Class II · Terminated · D-1396-2012 · Mefloquine hydrochloride

   Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

   Mefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Cart

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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