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,…

Source: FDA · August 11, 2026 · Ongoing · Official government notice

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