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Teva Pharmaceuticals USA Recalls
279 recalls on record · June 27, 2012 to May 13, 2026 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 19, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippa
Hazard: Failed Moisture Limits: Water (moisture) content above the approved product specifications.
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
May 31, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distribute
Hazard: Labeling: Incorrect or Missing Package Insert
April 12, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Ph
Hazard: Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
March 22, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine
Hazard: Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
March 15, 2023DrugsFDA
Teva Pharmaceuticals USA Inc recalls Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratori
Hazard: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
September 21, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Sa
Hazard: 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.
September 7, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North W
Hazard: 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.
August 17, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint La
Hazard: Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
August 10, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavi
Hazard: Failed Dissolution Specifications: below specification limits for dissolution.
August 10, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis
Hazard: Failed Dissolution Specifications: below specification limits for dissolution.
August 3, 2022DrugsFDA
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. Manufact
Hazard: Superpotent Drug: Out of specification assay result was obtained during stability testing.
June 29, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC
Hazard: Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
June 15, 2022DrugsFDA
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, Distr
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
June 8, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc.,
Hazard: Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
May 4, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-207
Hazard: cGMP Deviations
April 20, 2022DrugsFDA
Teva Pharmaceuticals USA Inc recalls IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmac
Hazard: Presence of Particulate Matter: Product was found to contain silica and iron oxide
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufa
Hazard: Mislabeling
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manuf
Hazard: Mislabeling
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-08
Hazard: Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
February 9, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufa
Hazard: Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
January 26, 2022DrugsFDA
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
Hazard: 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.
January 19, 2022DrugsFDA
Teva Pharmaceuticals USA recalls Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manuf
Hazard: Lack of Assurance of Sterility
January 19, 2022DrugsFDA
Teva Pharmaceuticals USA recalls MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactu
Hazard: Lack of Assurance of Sterility
December 29, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (N
Hazard: Subpotent
November 24, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, Manufactured by: Actavis Laboratories, UT I
Hazard: Failed Impurities/Degradation Specifications
November 24, 2021DrugsFDA
Teva Pharmaceuticals USA recalls Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufac
Hazard: Labelling: Incorrect Exp. Date