Recall D-0002-2026

US Class II Ongoing · initiated 2025-09-24

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

Product

Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Reason for recall

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

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