FDAHealthSeptember 4, 2025
Zydus Pharmaceuticals (USA) Inc — Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pen
⚠️ Failed Impurity/Degradation Specifications
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- September 4, 2025
U.S. Nationwide
What's affected?
- Product
- 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.
- Brand
- ENTECAVIR
- Lot code
- E309376
Additional details
Lot E309376; Exp 11/30/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 4344 bottles.
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