TemporaryFDAOngoing
Can cause harm that is usually temporary. Speak to your pharmacist or doctor — do not stop a prescribed medicine on your own.
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.
Check the label for
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Why
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Distributed
- Nationwide in the USA
- Company
- Zydus Pharmaceuticals (USA) Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Already ate or took it and feel unwell? Call Poison Control — 1-800-222-1222
Source: FDA record D-0745-2026 · retrieved 7 August 2026
Read the official notice