Recall D-0745-2026

US Class II Ongoing · initiated 2026-08-05

Recalling firm

Zydus Pharmaceuticals (USA) Inc, NJ

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.

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