Class II

Drug Recall: Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.

Zydus Pharmaceuticals (USA) Inc · September 4, 2025

Reason for Recall

Failed Impurity/Degradation Specifications

Distribution

U.S. Nationwide

States Affected

NATIONWIDE

Quantity Affected

4440 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0657-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.