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.

Recall Number: D-0001-2026

Firm: Zydus Pharmaceuticals (USA) Inc

Classification: Class II

Status: Ongoing

Report Date: 20251008

Initiation Date: 20250924

Termination Date:

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

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.