Recall: D-0745-2026

Class II - Potentially Harmful

Class IIClassification

2026-08-05Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

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.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.