Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Di
Recalled October 8, 2025 · FDA recall D-0001-2026 · Zydus Pharmaceuticals (USA)
Hazard
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity · FDA Class II
Units
912 30-count bottles
Sold at
Distributed Nationwide in the USA
Description
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Product
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.
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →