Class II

Drug Recall: 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,

Zydus Pharmaceuticals (USA) Inc · August 5, 2026

Reason for Recall

CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

Product Description

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.

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0745-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.