A widely prescribed generic medication for overactive bladder has been pulled from the market in one lot after testing found nitrosamine impurities above the limit regulators recommend. The recall covers 25 milligram mirabegron extended-release tablets in 30-count bottles distributed by Zydus Pharmaceuticals (USA) Inc., and it was initiated on August 5.
Federal records classify the action as a Class II recall. The FDA uses that designation for products where exposure may cause temporary or medically reversible health effects, or where the probability of serious harm is remote. It sits below the agency's most serious Class I category.
