Zydus Pharmaceuticals (USA) Inc recalls Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda,
Recalled August 12, 2026 · FDA recall D-0745-2026 · Zydus Pharmaceuticals (USA)
Hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. · FDA Class II
Sold at
Nationwide in the USA
Description
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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.
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →