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.
FDA recall notice · announced August 12, 2026 · Zydus Pharmaceuticals (usa)
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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 for recall
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Notes
Distribution: Nationwide in the USA
Lot/code information: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Status: Ongoing
Products in this recall event:
- 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, (D-0745-2026)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.