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Mirabegron
FDA recalls
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Summary of public sources, not medical advice. This page is an automated summary of public information from the FDA, the National Library of Medicine (DailyMed) and CMS Medicare data. It has not been reviewed by a doctor or pharmacist, may be incomplete, out of date or wrong, and does not list every use, dose, warning, interaction or side effect. Do not start, stop or change any medicine, or take a pill you cannot identify, based on this page: ask your doctor or pharmacist and read the official label. In an emergency call 911; for possible poisoning call Poison Control at 1-800-222-1222. Use of this page is subject to our Medical and Data Disclaimer and Terms of Use .
Date Company and reason Class
Aug 4, 2026 Zydus Pharmaceuticals (USA) Inc CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.Class II · Ongoing
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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).