Drug

Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Di

Recall date: 2026-08-12 · Source: FDA_DRUG

Brand / Firm

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.

Description

View official recall notice →