Recall: D-0656-2025

Class II - Potentially Harmful

Class IIClassification

2025-09-04Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

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

Distribution

U.S. Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.