Product: 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
Recall initiated: 20250924
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated