D-0745-2026 Class II Ongoing
FDA drug recall D-0745-2026 was initiated by Zydus Pharmaceuticals (USA) Inc on August 5, 2026 and is designated Class II. Reason for recall: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- August 12, 2026
- Initiation Date
- August 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
Reason for Recall
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3