Drug recall D-0745-2026
Product
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.
Lots and codes
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 5, 2026
Related products
- Mirabegron – drug information
- NDC 70710-1159 Mirabegron · Mirabegron 25 mg/1 · Zydus Pharmaceuticals (USA) Inc.
- NDC 70710-1160 Mirabegron · Mirabegron 50 mg/1 · Zydus Pharmaceuticals (USA) Inc.