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Teva Pharmaceuticals USA, Inc FDA Recalls
51 recalls on file across drugs, 2 of them Class I and 29 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, ZagClass IIAug 24, 2026Presence of Foreign Tablets/Capsules |
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mLClass IIApr 24, 2026Lack of Assurance of Sterility: Quality system deficiencies |
| Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packsClass IIApr 6, 2026Failed Impurities/Degradation Specifications: Out of specifi |
| Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, ManufactClass IIMar 19, 2026CGMP Deviations: use of an unapproved raw material |
| Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, ManufactClass IIMar 19, 2026CGMP Deviations: use of an unapproved raw material |
| Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, ManufactClass IIMar 19, 2026CGMP Deviations: use of an unapproved raw material |
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx onlClass IIMar 17, 2026Lack of Assurance of Sterility: Quality system deficiencies |
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx onlClass IIMar 17, 2026Lack of Assurance of Sterility: Quality system deficiencies |
| Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx onlClass IIMar 17, 2026Lack of Assurance of Sterility: Quality system deficiencies |
| Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NClass IIJan 29, 2026Failed Dissolution Specifications |
| Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tabletClass IIJan 29, 2026Failed Dissolution Specifications |
| Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles Class IIJan 29, 2026Failed Dissolution Specifications |
| Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles Class IIJan 29, 2026Failed Dissolution Specifications |
| Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc.Class IIJan 12, 2026Superpotent and Subpotent |
| Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc.Class IIJan 12, 2026Superpotent and Subpotent |
| Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: ActaviClass IIINov 7, 2025Defective Container - A defect in the side-seal which allows |
| Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx oClass IIOct 13, 2025Subpotent drug; Clavulanate Potassium component |
| Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194Class IIOct 7, 2025CGMP Deviations-Test results for N-nitroso Prazosin impurity |
| Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194Class IIOct 7, 2025CGMP Deviations-Test results for N-nitroso Prazosin impurity |
| Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194Class IIOct 7, 2025CGMP Deviations-Test results for N-nitroso Prazosin impurity |
| Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb, Class IIMay 23, 2025Presence of foreign tablets/capsules. |
| Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NClass IIJan 10, 2025Failed Stability Specifications - 12-month stability test re |
| Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, Class IIAug 8, 2024Superpotent Drug |
| Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., MClass IIJun 28, 2024Failed Impurities/Degradation Specifications: Product is bei |
| Amoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in CanadClass IIJun 4, 2024Subpotent Drug |
| Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva PharmaceuticalClass IIMar 28, 2024Superpotent Drug: The 3-month stability result for assay was |
| Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 BlClass IIMar 7, 2024Failed Dissolution Specifications |
| Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton conClass IIIJan 25, 2024Discoloration: discolored tablets (shades of blue) mixed in |
| Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister caClass IIIJan 25, 2024Discoloration: discolored tablets (shades of blue) mixed in |
| Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., FortClass IIJan 8, 2024Failed Dissolution Specifications |
| Testosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx only, Teva PharmaceuticaClass IIINov 10, 2023OOS for viscosity |
| Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., ParsippaClass IIJul 5, 2023Failed Moisture Limits: Water (moisture) content above the a |
| Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, DistributeClass IIIApr 27, 2023Labeling: Incorrect or Missing Package Insert |
| Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, DistributeClass IIIApr 27, 2023Labeling: Incorrect or Missing Package Insert |
| Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, DistributeClass IIIApr 27, 2023Labeling: Incorrect or Missing Package Insert |
| Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, DistributeClass IIIApr 27, 2023Labeling: Incorrect or Missing Package Insert |
| Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, DistributeClass IIIApr 27, 2023Labeling: Incorrect or Missing Package Insert |
| Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva PhClass IIIMar 27, 2023Failed Impurities/Degradation Specifications: failed impurit |
| Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, AntihistamineClass IIFeb 23, 2023Failed Impurities Specification: Out-of-specification (OOS) |
| Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis LaboratoriClass IIFeb 22, 2023CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) |
| Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed SaClass IIAug 29, 2022Labeling: Label Error on Declared Strength; A sealed 100-cou |
| Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North WClass IIAug 23, 2022CGMP Deviations: A foreign matter identified as teflon was f |
| Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint LaClass IIIJul 22, 2022Subpotent Drug - Out of specification (OOS) result obtained |
| Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: ActavisClass IIJul 21, 2022Failed Dissolution Specifications: below specification limit |
| Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: ActaviClass IIJul 21, 2022Failed Dissolution Specifications: below specification limit |
| Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. ManufactClass IIJun 29, 2022Superpotent Drug: Out of specification assay result was obta |
| Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC Class IIJun 14, 2022Failed Dissolution Specifications; Low Out of Specification |
| Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, DistrClass IIIMay 18, 2022Failed Impurities/Degradation Specifications; out-of-specifi |
| Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc.,Class IMay 11, 2022Failed Dissolution Specifications- Low Out-Of-Specification |
| Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-207Class IIApr 15, 2022cGMP Deviations |
| IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva PharmacClass IMar 29, 2022Presence of Particulate Matter: Product was found to contain |