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.

Check your package for

Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3

Why: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Distributed: Nationwide in the USA
Company: Zydus Pharmaceuticals (USA) Inc
Announced: 12 August 2026
Recall began: 5 August 2026

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