Zydus Pharmaceuticals (USA) Inc — Class II Recall

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.

Reason

Failed Impurity/Degradation Specifications

Classification

Class II

Status

Ongoing

Lot

Lot E309376; Exp 11/30/2025

Date

2025-09-24

Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.