Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distribu…

Recall date

September 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0657-2025

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

U.S. Nationwide

Why it was recalled

Failed Impurity/Degradation Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-921-06.