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Amneal Pharmaceuticals, Inc.

Amneal Pharmaceuticals, Inc. Recalls

All product recalls associated with Amneal Pharmaceuticals, Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

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 2581–2600 of 4747 recalls

Esterified Estrogens & Methyltestosterone Tablets (Amneal) – Subpotent Drug 0.625mg (2017)

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Class IIILow

FDASep 25, 2017Nationwide• Amneal Pharmaceuticals, Inc.

Esterified Estrogens & Methyltestosterone Tablets (Amneal) – Subpotent Drug 1.25mg (2017)

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

Class IIILow

FDASep 25, 2017Nationwide• Amneal Pharmaceuticals, Inc.

Mobic Tablets (Boehringer) – Incorrect Package Insert (2017)

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

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Class IIILow

FDASep 22, 2017CO, OH• Boehringer Ingelheim Pharmaceuticals, Inc.

Fluocinonide Gel (Taro) – Cross Contamination (2017)

Cross contamination with other products: traces of Dapsone were found in the finished product.

Class IIILow

FDASep 20, 2017Nationwide• Taro Pharmaceuticals U.S.A., Inc.

TYVASO Inhalation Solution (United Therapeutics) – Manufacturing Deviation (2017)

CGMP Deviations

Class IIModerate

FDASep 11, 2017PA• United Therapeutics Corp.

Alcohol Prep Pads (Simple Diagnostics) – Sterility Concern (2017)

Lack of Assurance of Sterility and cGMP Deviations

Class IIModerate

FDASep 5, 2017Nationwide• Simple Diagnostics, Inc.

Phentermine Capsules (Aidarex) – Impurity Specification Failure (2017)

Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test

Class IIILow

FDASep 5, 2017CA, NV• Aidarex Pharmaceuticals LLC

Enalapril Maleate Tablets (Aidarex) – Impurity Specification (2017)

Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.

Class IIILow

FDASep 5, 2017FL, IN• Aidarex Pharmaceuticals LLC

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

Urin D/S Tablets (Llorens) – Subpotent Drug (2017)

Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or Superpotent tablets.

Class IIModerate

FDASep 5, 2017PR• Llorens Pharmaceutical Corp.