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Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals of New York, LLC Recalls

All product recalls associated with Amneal Pharmaceuticals of New York, LLC.

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Recall Summary

Total Recalls

47

Past Year

7

Class I (Serious)

4

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 21–40 of 47 recalls

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

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

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

Page 2 of 3Next

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

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

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

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

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

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

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

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

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Nizatidine Oral Solution (Amneal) – NDMA Contamination Risk (2020)

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Class IIModerate

FDAApr 15, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Ranitidine Syrup (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 300mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Ranitidine Tablets 150mg (Amneal) – NDMA Impurity (2019)

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Class IIModerate

FDANov 22, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Isotretinoin Capsules (Amneal) – Impurity Specs (2019)

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

FDAOct 16, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Benazepril HCl Tablets (Amneal) – tablet contamination (2019)

Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle

FDASep 24, 2019Nationwide• Amneal Pharmaceuticals, Inc.

Methylergonovine Maleate Tablets (Amneal) – Foreign Tablet Detected (2019)

Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets

FDAJul 18, 2019Nationwide• Amneal Pharmaceuticals, Inc.