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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

266

Past Year

Class I (Serious)

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 101–120 of 266 recalls

Cephalexin Oral Suspension 250mg (Teva) – Potency Inconsistency (2020)

CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Cephalexin Oral Suspension 250mg (Teva) – Medication Potency (2020)

Sub-Potent Drug: Out of specification test results for potency (below specification).

Class IIModerate

FDAAug 24, 2020Nationwide• Teva Pharmaceuticals USA

Lidocaine Patch (Teva) – Labeling Deficiency (2020)

Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.

1...4 567 8...14

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Class II

Moderate

FDAJul 14, 2020Nationwide• Teva Pharmaceuticals USA

Metformin Hydrochloride Extended-Release (Teva) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 2, 2020Nationwide• Teva Pharmaceuticals USA

Metformin Hydrochloride Extended-Release (Teva) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAJun 2, 2020Nationwide• Teva Pharmaceuticals USA

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

Dextroamphetamine Tablets (Teva) – Mixed Strength Bottles (2020)

Some bottles may contain mixed strengths of the product.

Class IIModerate

FDAMay 22, 2020Nationwide• Teva Pharmaceuticals USA

Losartan Potassium 100mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Losartan Potassium 25mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Losartan Potassium 50mg Bulk (Teva) – CGMP Impurity Detection (2020)

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

FDAMar 25, 2020CA, IN• Teva Pharmaceuticals USA

Epinephrine Auto-Injector (Teva) – Trigger Force Problem (2020)

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

Class IIModerate

FDAMar 5, 2020OR• Teva Pharmaceuticals USA

Mesalamine Tablets (Teva) – Dissolution Specification Failure (2020)

Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.

Class IIModerate

FDAFeb 20, 2020Nationwide• Teva Pharmaceuticals USA

Tramadol Tablets (Teva) – Incorrect Package Insert (2020)

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.

Class IIILow

FDAJan 28, 2020Nationwide• Teva Pharmaceuticals USA