Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahme...
FDA Recall #D-0657-2025 — Class II — September 4, 2025
Product Description
Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
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
4440 bottles
Distribution
U.S. Nationwide
Code Information
Lot E309377, Exp 11/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated