D-0657-2025 Class II Ongoing
FDA drug recall D-0657-2025 was initiated by Zydus Pharmaceuticals (USA) Inc on September 4, 2025 and is designated Class II. Reason for recall: Failed Impurity/Degradation Specifications The recall status is ongoing. Affected quantity: 4440 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- September 24, 2025
- Initiation Date
- September 4, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4440 bottles
Product Description
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.
Reason for Recall
Failed Impurity/Degradation Specifications
Distribution Pattern
U.S. Nationwide
Code Information
Lot E309377, Exp 11/30/2025