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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.
June 10, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A
Hazard: Some bottles may contain mixed strengths of the product.
June 10, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed A
Hazard: Some bottles may contain mixed strengths of the product.
May 13, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pha
Hazard: CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
April 15, 2020DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactu
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
April 15, 2020DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactu
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
April 15, 2020DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactur
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
March 11, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,
Hazard: Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
February 26, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles
Hazard: Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
February 19, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals
Hazard: CGMP deviations: Product bottle may be absent of desiccant.
February 19, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals
Hazard: CGMP deviations: Product bottle may be absent of desiccant.
February 12, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauder
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
February 12, 2020DrugsFDA
Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauder
Hazard: GMP Deviations: Product bottle may be absent of desiccant.
November 27, 2019DrugsFDA
Teva Pharmaceuticals USA, Inc. recalls Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavi
Hazard: Presence of foreign substance: Brown/black particles found during stability testing.
October 16, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis
Hazard: GMP Deviation: lot not intended for commercial distribution.
July 17, 2019DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
April 24, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle
Hazard: Subpotent Product: assay results for Amoxicillin were below the specification limits.
March 27, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx
Hazard: Subpotent Drug.
January 23, 2019DrugsFDA
Teva Pharmaceuticals USA recalls Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg, packaged in a) 30-count bottle (NDC 0093-7617-56), b)
Hazard: Failed dissolution specifications
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 9
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) &
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
November 21, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA,
Hazard: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratori
Hazard: Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.