Class II
Ongoing
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.
This recall is currently active, issued September 24, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- September 4, 2025
- Posted
- September 24, 2025
- Recall Number
- D-0657-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4440 bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution
U.S. Nationwide
Lot / Code Info
Lot E309377, Exp 11/30/2025
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