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.
Recall Number: D-0657-2025
Firm: Zydus Pharmaceuticals (USA) Inc
Classification: Class II
Status: Ongoing
Report Date: 20250924
Initiation Date: 20250904
Termination Date:
Reason for Recall
Failed Impurity/Degradation Specifications
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.