Bladder Medication Recalled Nationwide Over Cancer-Linked Impurity
A widely prescribed generic medication for overactive bladder has been recalled after testing found levels of a potentially cancer-linked impurity above the limit federal regulators recommend.
The recall covers one lot of 25-milligram mirabegron extended-release tablets, sold in 30-count bottles and distributed by Zydus Pharmaceuticals (USA) Inc. The action was initiated Aug. 5 and is classified by the FDA as a Class II recall, a designation used for products where exposure may cause temporary or medically reversible health effects, or where the chance of serious harm is considered remote. It sits below the agency's more serious Class I classification.
Which Bottles Are Affected
The recall applies specifically to mirabegron extended-release tablets in the 25-milligram, 30-count bottle size, carrying lot code E408618 and National Drug Code 70710-1159-3, with an expiration date of Nov. 30, 2026. The tablets were manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India. Anyone with a prescription for mirabegron is advised to check their bottle against these details, since only this specific lot is included in the recall.
Why the Medication Was Pulled
Mirabegron is a beta-3 adrenergic agonist approved to treat overactive bladder in adults experiencing urinary urgency, frequency or urge incontinence. The recalled lot tested positive for nitrosamine impurities exceeding the level the FDA recommends as safe. Nitrosamines are a class of compounds that, at elevated levels, have been linked to an increased cancer risk over long-term exposure, though a single lot exceeding a specification reflects a manufacturing quality failure rather than confirmed evidence that anyone who took the tablets will develop cancer.
Manufacturers are required to detect and limit nitrosamine impurities under FDA guidance, and lots that fall outside acceptable limits are subject to recall even when no illnesses have been reported.
What to Do If You Have This Medication
Patients who have filled a mirabegron prescription are advised to check their bottle for the affected lot code and NDC number. Those with the recalled product should contact their pharmacy for a refund or replacement. The FDA and manufacturers generally advise patients not to stop taking a prescribed medication without first consulting their doctor or pharmacist, even amid a recall, given the risks of discontinuing treatment abruptly.
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