Recall D-0002-2026
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