The edition · Urology
Mirabegron tablets recalled over a nitrosamine impurity
An ongoing Class II FDA recall covers mirabegron extended-release 25 mg tablets after an out-of-specification result for N-nitroso mirabegron, the EAU has restructured its urological infections guidelines around a new UTI classification, and adding tolterodine to tamsulosin improved distal ureteral stone expulsion from 66.7% to 83.3%.
The edition in brief
Today's regulatory news is a genuine drug action. The FDA has an ongoing Class II recall of mirabegron extended-release 25 mg tablets, 30-count bottles, manufactured by Zydus Lifesciences in Ahmedabad and distributed by Zydus Pharmaceuticals USA. The cause is a current good manufacturing practice failure: an out-of-specification result for N-nitroso mirabegron, a nitrosamine impurity. Class II means temporary or medically reversible harm is possible. Mirabegron is widely prescribed for overactive bladder and often taken for years, so the relevant question for any patient on it is who manufactured their tablets. The European Association of Urology has published its 2026 urological infections guidelines, comprehensively restructured around a new classification system for urinary tract infection, with new chapters on herpes simplex virus and on fungal urinary tract infection, and updated recommendations on periprocedural antibiotic prophylaxis for prostate biopsy. Antimicrobial stewardship is a stated organising theme. A network meta-analysis of five phase III trials and 5,317 patients compared vibegron, mirabegron and tolterodine for overactive bladder. Vibegron ranked best for urgency episodes, urgency incontinence and maximum voided volume; mirabegron ranked best for urinary frequency and was least associated with hypertension. Adverse event definitions varied widely between trials. In 120 patients with distal ureteral stones of 4-10 mm, adding tolterodine to tamsulosin raised expulsion from 66.7% to 83.3% and shortened expulsion time from 14.8 to 10.5 days.
Class II recall of mirabegron tablets for a nitrosamine impurity
An ongoing Class II recall covers Zydus-manufactured mirabegron extended-release 25 mg tablets over a nitrosamine impurity, so ask patients on long-term mirabegron to check the manufacturer of their supply rather than stopping the drug.
The EAU has rebuilt its urological infections guidance around a new UTI classification
The EAU's 2026 urological infections guidelines are restructured around a new UTI classification, with new chapters on herpes simplex and fungal UTI and updated prostate biopsy prophylaxis — though antibiotic choices should still be checked against local resistance.
Vibegron, mirabegron and tolterodine ranked, in the absence of head-to-head trials
Indirect comparison ranks vibegron ahead for urgency and incontinence episodes and mirabegron ahead for frequency and lower hypertension risk, but no head-to-head trial exists and the safety comparisons rest on inconsistent reporting.
Adding tolterodine to tamsulosin sped up distal stone expulsion
Adding tolterodine to tamsulosin raised distal ureteral stone expulsion from 66.7% to 83.3% and shortened expulsion time by four days in a single-centre trial of 120 patients, which merits a larger trial before changing practice.
Ask who made the tablet, not just what it is
When a nitrosamine recall is announced, tell patients to take their bottle to the pharmacy to check the manufacturer and lot rather than stopping, because abrupt discontinuation causes certain harm to prevent an uncertain one.
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