Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distrib
Recalled September 24, 2025 · FDA recall D-0656-2025 · Zydus Pharmaceuticals (USA)
Hazard
Failed Impurity/Degradation Specifications · FDA Class II
Units
4344 bottles
Sold at
U.S. Nationwide
Description
Failed Impurity/Degradation Specifications
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.
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →