Class II

Drug Recall: 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-

Zydus Pharmaceuticals (USA) Inc · September 24, 2025

Reason for Recall

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

Product Description

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.

Distribution

Distributed Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

912 30-count bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0001-2026

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.