Class II recall of mirabegron tablets for a nitrosamine impurity

Today's sweep found a real drug action rather than a quiet day. The FDA has an ongoing Class II recall covering mirabegron extended-release 25 mg tablets in 30-count bottles, manufactured by Zydus Lifesciences at Matoda, Ahmedabad, and distributed by Zydus Pharmaceuticals USA. The reason is a current good manufacturing practice failure: an out-of-specification result for N-nitroso mirabegron.

Nitrosamines are the impurity class behind the ranitidine, valsartan and metformin recalls of recent years. They are probable human carcinogens, and the concern is cumulative exposure rather than acute harm — which is why the classification is Class II, meaning temporary or medically reversible adverse consequences are possible, rather than Class I. Mirabegron is taken for overactive bladder, a chronic condition, so patients are typically exposed for years rather than weeks.

The practical step is specific. A patient on mirabegron cannot tell from the drug name whether their supply is affected; it depends on the manufacturer and the lot. Ask patients on mirabegron to check the manufacturer on their bottle or with their pharmacist, and to raise it rather than stopping abruptly — overactive bladder symptoms return quickly and there are alternatives, as today's comparative data show. This is also worth flagging to prescribing colleagues in primary care, where most repeat mirabegron prescriptions actually originate.

• Class II recall: mirabegron ER 25 mg, 30-count bottles, Zydus, ongoing
• Cause is an out-of-specification N-nitroso mirabegron result
• Nitrosamine risk is cumulative, and mirabegron is taken long term
• Ask patients to check the manufacturer rather than stopping abruptly

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