Teva Pharmaceuticals recalls
44 official recalls and safety alerts involving Teva Pharmaceuticals since 2021-10, from FDA · Drug. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Teva Pharmaceuticals or the relevant agency.
- 2026-09-09
US- 2026-05-13
- US
Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- 2026-04-29
- US
Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC…
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
FDA · DrugTeva Pharmaceuticals USA, IncNationwide in the USA, Puerto Rico and Virgin IslandsOfficial notice → - 2026-04-15
- US
Teva Pharmaceuticals USA, Inc recalls Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only, Manufactured by:…
CGMP Deviations: use of an unapproved raw material
- US
- 2026-04-01
- US
Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only,…
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- 2026-03-11
- US
- 2025-12-10
- US
Teva Pharmaceuticals USA, Inc recalls Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis…
Defective Container - A defect in the side-seal which allows leakage of product.
- 2025-11-12
- US
Teva Pharmaceuticals USA, Inc recalls Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only,…
Subpotent drug; Clavulanate Potassium component
FDA · DrugTeva Pharmaceuticals USA, IncDistributed in three (3) States: MS, OH, CA.Official notice → - 2025-11-05
- US
Teva Pharmaceuticals USA, Inc recalls Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100…
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.
- 2025-07-02
- US
- 2025-02-12
- US
Teva Pharmaceuticals USA, Inc recalls Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC…
Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
- 2024-08-28
- US
Teva Pharmaceuticals USA, Inc recalls Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454,…
Superpotent Drug
FDA · DrugTeva Pharmaceuticals USA, IncProduct was distributed nationwide within the United StatesOfficial notice → - 2024-07-24
- US
Teva Pharmaceuticals USA, Inc recalls Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc.,…
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.
- 2024-06-26
- US
- 2024-04-17
- US
Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc.,…
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
- 2024-04-03
- US
- 2024-02-21
- US
Teva Pharmaceuticals USA, Inc recalls Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each…
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
- 2024-02-07
- US
- 2023-12-06
- US
- 2023-07-19
- US
Teva Pharmaceuticals USA Inc recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ…
Failed Moisture Limits: Water (moisture) content above the approved product specifications.
FDA · DrugTeva Pharmaceuticals USA IncProduct was distributed to 3 wholesalers/distributors who further distributed…Official notice → - 2023-05-31
- US
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne…
Labeling: Incorrect or Missing Package Insert
- 2023-04-12
- US
Teva Pharmaceuticals USA Inc recalls Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva…
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
- 2023-03-22
- US
Teva Pharmaceuticals USA Inc recalls Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL…
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
- 2023-03-15
- US
Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL,…
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
- 2022-09-21
- US
Teva Pharmaceuticals USA Inc recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a…
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.
- 2022-09-07
- US
Teva Pharmaceuticals USA Inc recalls Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA…
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.
- 2022-08-17
- US
Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories,…
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- 2022-08-10
- US
Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis…
Failed Dissolution Specifications: below specification limits for dissolution.
- 2022-08-03
- US
Teva Pharmaceuticals USA Inc recalls Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by:…
Superpotent Drug: Out of specification assay result was obtained during stability testing.
- 2022-06-29
- US
Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- 2022-06-15
- US
Teva Pharmaceuticals USA Inc recalls Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by:…
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
FDA · DrugTeva Pharmaceuticals USA IncProduct was distributed nationwide in the US MarketOfficial notice → - 2022-06-08
- US
Teva Pharmaceuticals USA Inc recalls Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North…
Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
- 2022-05-04
- US
- 2022-04-20
- US
Teva Pharmaceuticals USA Inc recalls IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals,…
Presence of Particulate Matter: Product was found to contain silica and iron oxide
- 2022-02-09
- US
- US
Teva Pharmaceuticals USA recalls Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
- US
Teva Pharmaceuticals USA recalls Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by:…
Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
- 2022-01-26
- US
Teva Pharmaceuticals USA recalls Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC…
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.
- 2022-01-19
- US
Teva Pharmaceuticals USA recalls MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for:…
Lack of Assurance of Sterility
FDA · DrugTeva Pharmaceuticals USAMethylprednisolone, TN Norepinephrine BItartrate - MS, OHOfficial notice → - 2021-12-29
- US
- 2021-11-24
- US
Teva Pharmaceuticals USA recalls Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT Inc., Salt Lake…
Failed Impurities/Degradation Specifications
- US
- 2021-10-27
- US
Teva Pharmaceuticals USA recalls AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva Respiratory, LLC…
Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol