D-0001-2026 Class II Ongoing
FDA drug recall D-0001-2026 was initiated by Zydus Pharmaceuticals (USA) Inc on September 24, 2025 and is designated Class II. Reason for recall: Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity The recall status is ongoing. Affected quantity: 912 30-count bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 8, 2025
- Initiation Date
- September 24, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 912 30-count bottles
Product Description
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.
Reason for Recall
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot#: E409308, Exp 12/31/2026