The FDA has issued a Class II recall for one lot of mirabegron extended‑release 25 mg tablets, a prescription medication used to treat overactive bladder. The recall was initiated after testing detected an N‑nitroso impurity above acceptable limits.
Recalled Product Details
- Mirabegron ER Tablets, 25 mg (30‑count bottle)
- Lot Number: E408618
- Manufacturer: Zydus Lifesciences / Zydus Pharmaceuticals
- Reason: Out‑of‑specification N‑Nitroso Mirabegron impurity
- Expiration: November 2026
Public Safety Guidance Patients should check their bottle for the affected lot number. Anyone with the recalled product should stop using it immediately and contact their pharmacy for replacement or further instructions. Nitrosamine impurities may pose health risks with long‑term exposure.
For questions, the FDA’s consumer line is available at 1.888.463.6332
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