Recall: D-0426-2024

Class II - Potentially Harmful

Class IIClassification

2023-12-26Initiated

TerminatedStatus

Amneal Pharmaceuticals of New Firm

Product

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

Reason

Failed dissolution specifications

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.