Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd...
FDA Recall #D-0001-2026 — Class II — September 24, 2025
Product Description
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, 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:Out of Specification result for an individual organic impurity
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
912 30-count bottles
Distribution
Distributed Nationwide in the USA
Code Information
Lot#: E409308, Exp 12/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated