Class IIReported 2025-09-24

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.

Recalled by Zydus Pharmaceuticals (USA) Inc

Reason for Recall

Failed Impurity/Degradation Specifications

Recall Number

D-0656-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-09-04

Reported

2025-09-24

Distribution

U.S. Nationwide

Code Info

Lot E309376; Exp 11/30/2025

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.