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Amneal Pharmaceuticals, LLC

Amneal Pharmaceuticals, LLC Recalls

All product recalls associated with Amneal Pharmaceuticals, LLC.

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Recall Summary

Total Recalls

20

Past Year

7

Class I (Serious)

2

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 1–20 of 20 recalls

Chlorpromazine Hydrochloride 100mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 50mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Sulfamethoxazole Trimethoprim (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 200mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Chlorpromazine Hydrochloride 25mg (Amneal Pharmaceuticals) - Foreign Substance (2025)

Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 18, 2025Nationwide• Amneal Pharmaceuticals, LLC

Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

FDAJun 2, 2025Nationwide• Amneal Pharmaceuticals, LLC

Ropivacaine Hydrochloride Injection (Amneal) – Particulate Matter (2025)

Presence of Particulate Matter

FDAApr 17, 2025Nationwide• Amneal Pharmaceuticals, LLC

Methotrexate Tablets (Amneal) – Foreign Tablet Contamination (2024)

Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.

FDAAug 1, 2024Nationwide• Amneal Pharmaceuticals, 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

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 (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

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