FDARecalled Aug 12, 2026 · #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., Penningto...
Hazard
Class II — temporary health risk
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CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Model numbers
- E408618
- UPCs
- —