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Teva Pharmaceuticals USA Inc

Teva Pharmaceuticals USA Inc Recalls

All product recalls associated with Teva Pharmaceuticals USA Inc.

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Recall Summary

Total Recalls

265

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 21–40 of 265 recalls

Fentanyl Buccal Tablets CII 400mcg (Teva) – Missing Package Insert (2023)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAApr 27, 2023Nationwide• Teva Pharmaceuticals USA Inc

Fentanyl Buccal Tablets (Teva) – Labeling Error (2023)

Labeling: Incorrect or Missing Package Insert

Class IIILow

FDAApr 27, 2023Nationwide• Teva Pharmaceuticals USA Inc

Montelukast Sodium Granules (Teva) – Impurity Specification Failure (2023)

Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

Class III

123 4...14

Page 2 of 14Next

Low

FDAMar 27, 2023Nationwide• Teva Pharmaceuticals USA Inc

Clear Eyes Allergy Relief (Teva) – impurity specification failure (2023)

Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

Class IIModerate

FDAFeb 23, 2023Nationwide• Teva Pharmaceuticals USA Inc

Metformin Extended-Release (Teva) – NDMA contamination (2023)

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Class IIModerate

FDAFeb 22, 2023CA• Teva Pharmaceuticals USA Inc

ADHD Medication (Teva) – Strength Labeling Error (2022)

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.

Class IIModerate

FDAAug 29, 2022Nationwide• Teva Pharmaceuticals USA Inc

Neomycin Sulfate Tablets (Teva) – CGMP Deviations (2022)

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.

Class IIModerate

FDAAug 23, 2022Nationwide• Teva Pharmaceuticals USA Inc