Official recall notice
FDA DrugClass IINotable
FDA Recall: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesci
- Recall date
- 2026-08-12
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Product description
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Affected products
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3