Zydus Pharmaceuticals (USA) Inc recalls Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, D…
- Recall date
- September 24, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0001-2026
- FDA classification
- Class II
- Brand / firm
- Zydus Pharmaceuticals (USA) Inc
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
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, 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.
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