Class II

Drug Recall: 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, Bridgewate

Amneal Pharmaceuticals of New York, LLC · December 26, 2023

Reason for Recall

Failed dissolution specifications

Product Description

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

Distribution

Product was distributed nationwide.

States Affected

NATIONWIDE

Quantity Affected

21,452/100 count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0426-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.