Class IIReported 2025-10-08

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.

Reason for Recall

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

Recall Number

D-0001-2026

Classification

Class II

Status

Ongoing