Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What was recalled
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.
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- NDC code
- 70710-1159-3
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0745-2026
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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