FDAFDA · Food and drugs·Recall number D-0745-2026
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.
Published August 12, 2026 · Recall initiated: August 5, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MIRABEGRON
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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