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Amneal Pharmaceuticals

Amneal Pharmaceuticals Recalls

All product recalls associated with Amneal Pharmaceuticals.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Aug 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 41–47 of 47 recalls

Fosphenytoin Sodium Injection (Amneal) – Particulate Matter (2017)

Presence of particulate matter

Class IIModerate

FDADec 15, 2017Nationwide• Amneal Pharmaceuticals

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.

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

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

Class III

1 23

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Low

FDASep 25, 2017Nationwide• Amneal Pharmaceuticals, Inc.

Fosphenytoin Sodium Injection (Amneal) – Particulate Matter (2017)

Presence of Particulate Matter

Class IIModerate

FDAAug 31, 2017MS, NC, OH +2 more• Amneal Pharmaceuticals LLC

Lorazepam Oral Concentrate (Amneal) – Defective Dropper (2017)

Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.

Class IHigh

FDAAug 3, 2017Nationwide• Amneal Pharmaceuticals of New York, LLC

Rabeprazole Sodium Tablets (Amneal) – Failed Dissolution (2016)

Failed Dissolution Specifications

Class IIModerate

FDADec 12, 2016Nationwide• Amneal Pharmaceuticals LLC

Extended Phenytoin Sodium Capsules (Amneal) – Dissolution Specifications (2013)

Failed dissolution specifications; 18 month CRT

Class IIModerate

FDAAug 17, 2013IL, NH, NJ +4 more• Amneal Pharmaceuticals of New York, LLC.