Recall D-0656-2025

US Class II Ongoing · initiated 2025-09-04

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

Product

Entecavir Tablets, USP, 0.5 mg, 30 Tablets, 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

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