Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ah...
FDA Recall #D-0656-2025 — Class II — September 4, 2025
Product Description
Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason for Recall
Failed Impurity/Degradation Specifications
Recalling Firm
Zydus Pharmaceuticals (USA) Inc — Pennington, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4344 bottles
Distribution
U.S. Nationwide
Code Information
Lot E309376; Exp 11/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated