FDA logs a Class II recall of mirabegron ER for a nitrosamine impurity

The regulatory sweep found no new drug approval for urology today, but it did surface a safety action worth knowing while prescribing for overactive bladder: a Class II FDA recall of mirabegron extended-release tablets (25 mg, Zydus), for an out-of-specification result for the N-nitroso-mirabegron impurity. The recall is ongoing.

Nitrosamine impurities are a theoretical long-term carcinogenic concern rather than an acute risk, and a Class II recall means the probability of serious harm is low. Patients should not stop mirabegron abruptly on their own; the practical step is to check whether dispensed stock is from an affected lot and to switch supplier or agent if needed.

Beyond drug recalls, the guidance shaping urology now is the 2026 EAU prostate cancer update — risk-adapted screening from age 50, mpMRI before biopsy, a new five-tier classification, and PSMA PET as the most sensitive staging tool — which is the document to read alongside today's trial findings.

• Class II recall of mirabegron ER 25 mg (Zydus) for a nitrosamine (N-nitroso-mirabegron) impurity
• Low probability of serious harm; do not advise abrupt discontinuation
• Check dispensed lots; switch supplier or agent if affected stock is involved
• The 2026 EAU prostate cancer guidelines are the current framework for screening and staging

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