Amneal Pharmaceuticals of New York, LLC recalls Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals P…

Recall date

December 26, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0426-2024

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Product was distributed nationwide.

Why it was recalled

Failed dissolution specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10