Class II
Drug Recall: Entecavir Tablets, USP, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-92
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, 1 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.
Distribution
Distributed Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
600 30-count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0002-2026
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.