Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- Product
- 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.
- Reason
- CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 5, 2026
- Reported
- Aug 12, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Lot / codes
- Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0745-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0745-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.