Several Class II recalls affecting this desk have come through the registers. Mirabegron extended-release tablets 25 mg in 30-count bottles, manufactured in Ahmedabad, are subject to recall. Separately, bulk sildenafil citrate and tadalafil active pharmaceutical ingredient supplied for prescription compounding, in bag quantities from 100 g to 1 kg, have been recalled by their manufacturer. A supplemental application on a generic tadalafil was also approved. A Class II recall means the product may cause temporary or reversible harm; it is not a withdrawal, and unaffected batches remain in use. If a patient's overactive bladder control has deteriorated on the same prescription, check the batch before changing drug.
The substantive change in guidance is the 2026 AUA and SUO update to the non-muscle-invasive bladder cancer guideline. The systematic search covered new evidence from May 2023 to December 2025, screening 2,933 studies down to 38 in the final evidence base. Updates were made to risk stratification itself, and to statements on biomarkers, subtype histologies, transurethral resection, intravesical therapy, BCG maintenance and enhanced cystoscopy. Given how much has changed in intravesical therapy since 2023, and the persistent BCG supply problems, the risk stratification and intravesical sections are the ones to read first rather than skimming the summary.
What this sweep does not see: CDSCO alerts, national BCG supply notices and USI or society statements published as web pages are outside it entirely. Check those directly.
- Check mirabegron batch numbers against the recall before attributing loss of effect to the patient.
- Compounded sildenafil and tadalafil from recalled bulk powder should be identified and quarantined.
- Read the revised NMIBC risk stratification first; the categories themselves changed, not just the treatments.
- Revisit your BCG maintenance schedule against the updated statements, particularly under supply constraint.
- CDSCO notifications and national supply notices are outside this sweep; check them yourself.
The statistics, in plain English
A Class II recall denotes a product that may cause temporary or medically reversible harm, with serious harm unlikely — a different category from the Class I recalls that signal a probability of serious injury or death. In a guideline update, screening 2,933 studies down to 38 is normal and reflects how little new evidence meets inclusion criteria; the size of the search says nothing about the strength of the resulting recommendations.
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