Class II
Ongoing
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.
This recall is currently active, issued October 8, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- September 24, 2025
- Posted
- October 8, 2025
- Recall Number
- D-0001-2026
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 912 30-count bottles
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Distribution
Distributed Nationwide in the USA
Lot / Code Info
Lot#: E409308, Exp 12/31/2026
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