Recall: D-0001-2026

Class II - Potentially Harmful

Class IIClassification

2025-09-24Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

Product

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.

Reason

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

Distribution

Distributed Nationwide in the USA

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