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Teva Pharmaceuticals USA

Teva Pharmaceuticals USA Recalls

All product recalls associated with Teva Pharmaceuticals USA.

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Recall Summary

Total Recalls

265

Past Year

6

Class I (Serious)

6

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 121–140 of 265 recalls

Losartan Potassium 100mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Losartan Potassium 50mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Amoxicillin Suspension (Teva) – Subpotent Product (2019)

Subpotent Product: assay results for Amoxicillin were below the specification limits.

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Class IIModerate

FDAApr 12, 2019Nationwide• Teva Pharmaceuticals USA

Lansoprazole Orally Disintegrating Tablets (Teva) – Subpotent Drug (2019)

Subpotent Drug.

FDAMar 11, 2019Nationwide• Teva Pharmaceuticals USA

Olmesartan/Hydrochlorothiazide Tablets (Teva) – Failed Dissolution (2018)

Failed dissolution specifications

Class IIModerate

FDADec 19, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine, Valsartan, Hydrochlorothiazide (Teva) – impurity risk (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Amlodipine & Valsartan (Teva) – NDEA Contamination (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDANov 27, 2018Nationwide• Teva Pharmaceuticals USA

Metoprolol Succinate Tablets (Teva) – Dissolution Test Failure (2018)

Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Teva Pharmaceuticals USA

Alprostadil Injection (Teva Pharmaceuticals) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Class IIModerate

FDASep 27, 2018Nationwide• Teva Pharmaceuticals USA

Clozapine Tablets (Teva Pharmaceuticals) – Disintegration Failure (2018)

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

Class IIModerate

FDASep 21, 2018Nationwide• Teva Pharmaceuticals USA

Clonazepam Tablets (Teva Pharmaceuticals) – Stability Failure (2018)

Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.

Class IIModerate

FDASep 20, 2018Nationwide• Teva Pharmaceuticals USA

Metformin Tablets (Teva) – Defective Delivery System (2018)

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Class IIModerate

FDAAug 6, 2018Nationwide• Teva Pharmaceuticals USA

Fortamet Tablets (Teva) – Delivery System Defect (2018)

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Class IIModerate

FDAAug 6, 2018Nationwide• Teva Pharmaceuticals USA

Paliperidone Tablets (Teva) – Delivery System Defect (2018)

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Class IIModerate

FDAAug 6, 2018Nationwide• Teva Pharmaceuticals USA