Class II · Posted August 12, 2026 · Started August 5, 2026 · Ongoing
mirabegron
- 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.
- Firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Reason
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Lots
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Distribution
- Nationwide in the USA
- RxNorm
- mirabegron (RxCUI 1300791, 1300801)
- Recall number
- D-0745-2026