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

26

Past Year

0

Class I (Serious)

2

Most Recent

Mar 2024

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 26 recalls

Methylergonovine Tablets (Amneal) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAMar 25, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Vancomycin Oral Solution (Amneal) – Superpotent Dosage (2024)

Superpotent Drug: Due to overfilling of drug powder

Class IHigh

FDAMar 21, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Oseltamivir Phosphate Suspension (Amneal) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Class II

Moderate

FDAFeb 13, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Phenoxybenzamine Hydrochloride Capsules (Amneal) – Impurity Specification (2024)

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Class IIModerate

FDAJan 15, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Divalproex Sodium Extended-Release Tablets (Amneal) – Dissolution Failure (2023)

Failed dissolution specifications

Class IIModerate

FDADec 26, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Phenytoin Sodium Capsules 100mg (Amneal) – failed dissolution (2023)

Failed Dissolution Specifications

Class IIModerate

FDAOct 27, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Extended Phenytoin Sodium Capsules (Amneal) – Dissolution Failure (2023)

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Class IIModerate

FDAMay 30, 2023LA, OH, PA• Amneal Pharmaceuticals of New York, LLC

Methylprednisolone Acetate (Amneal) – Labeling Error (2023)

Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.

Class IIILow

FDAMay 8, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Divalproex Sodium Tablets (Amneal) – Dissolution Failure (2022)

Failed dissolution specifications.

Class IIModerate

FDAJul 27, 2022Nationwide• Amneal Pharmaceuticals of New York, LLC

Flocinolone Acetonide Scalp Oil (Amneal) – Subpotent Drug (2021)

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Class IIModerate

FDANov 4, 2021Nationwide• Amneal Pharmaceuticals of New York, LLC

Flocinolone Acetonide Body Oil (Amneal) – Subpotent Drug (2021)

Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.

Class IIModerate

FDANov 4, 2021Nationwide• Amneal Pharmaceuticals of New York, LLC