Class IIOngoing

Entecavir Tablets recall

FDA recall D-0657-2025 · initiated Sep 4, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Impurity/Degradation Specifications

Details

Product: 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.
Recalling company: Zydus Pharms USA
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Sep 4, 2025
FDA report date: Sep 24, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0657-2025 ↗

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