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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

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 161–180 of 265 recalls

Fentanyl 75mcg Patch (Teva) – Degradation Risk (2018)

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Class IIILow

FDAJan 29, 2018Nationwide• Teva Pharmaceuticals USA

Fentanyl 50mcg Patch (Teva) – Degradation Risk (2018)

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Class IIILow

FDAJan 29, 2018Nationwide• Teva Pharmaceuticals USA

Moexipril Hydrochloride Tablets (Teva) – Impurity Specification (2017)

Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.

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Class IIModerate

FDADec 14, 2017Nationwide• Teva Pharmaceuticals USA

Penicillin V Potassium Solution (Teva) – Impurity Specifications (2017)

Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.

Class IIILow

FDANov 28, 2017Nationwide• Teva Pharmaceuticals USA

Amethyst Birth Control (Teva) – Labeling Instruction Error (2017)

Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.

Class IIModerate

FDANov 20, 2017Nationwide• Teva Pharmaceuticals USA

Clozapine 100 mg Tablets (Teva) – tablet specification issues (2017)

Failed Tablet/Capsule Specifications; potential presence of broken tablets.

Class IIModerate

FDANov 9, 2017Nationwide• Teva Pharmaceuticals USA

Dutasteride Tamsulosin Capsules (Teva) – Dissolution Failure (2017)

Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.

Class IIModerate

FDAOct 25, 2017Nationwide• Teva Pharmaceuticals USA

Methylphenidate Tablets (Teva) – Dissolution Failure (2017)

Failed Dissolution Specifications: Low out of specification results for dissolution.

Class IIILow

FDAOct 17, 2017Nationwide• Teva Pharmaceuticals USA

Acarbose Tablets (Teva) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.

Class IIModerate

FDASep 5, 2017Nationwide• Teva Pharmaceuticals USA

Glipizide Extended-Release Tablets (Teva) – Moisture Limit Failure (2017)

Failed Moisture Limits: out of specification test results for water content obtained during stability testing.

Class IIILow

FDAAug 2, 2017CT, IL, MI +3 more• Teva Pharmaceuticals USA

Albuterol Sulfate Inhalation Solution (Teva) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

Class IIILow

FDAJul 25, 2017Nationwide• Teva Pharmaceuticals USA

Famotidine Tablets (Teva) – Weight Specification Issue (2017)

Failed Tablet/Capsule Specification; out of specification for tablet weight

Class IIModerate

FDAJul 24, 2017Nationwide• Teva Pharmaceuticals USA

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Class IIILow

FDAJun 29, 2017Nationwide• Teva Pharmaceuticals USA

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.

Class IIILow

FDAJun 29, 2017Nationwide• Teva Pharmaceuticals USA

Clozapine Tablets (Teva) – Microbial Contamination (2017)

Microbial Contamination of Non-Sterile Products

Class IIModerate

FDAApr 24, 2017Nationwide• Teva Pharmaceuticals USA

PrednisoLONE Oral Solution (Teva) – stability failure (2017)

Failed Stability Specifications

Class IIILow

FDAMar 28, 2017Nationwide• Teva Pharmaceuticals USA

Risedronate Sodium Tablets (Teva) – Dissolution Specification Failure (2017)

Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.

Class IIILow

FDAFeb 17, 2017Nationwide• Teva Pharmaceuticals USA

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 7, 2017Nationwide• Teva Pharmaceuticals USA

Mimvey Lo Tablets (Teva) – impurity specification (2017)

Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.

Class IIModerate

FDAFeb 2, 2017Nationwide• Teva Pharmaceuticals USA

Amoxicillin Suspension (Teva) – Subpotency Concern (2016)

Subpotency: due to a low, out of specification test result for assay during stability testing.

Class IIModerate

FDADec 21, 2016Nationwide• Teva Pharmaceuticals USA