Mirabegron Tablets Recalled Due to CGMP Deviations

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for mirabegron extended-release tablets, 25 mg. The affected batch has been identified as Lot E408618 (expires November 2026).
• The recall was initiated by Zydus Pharmaceuticals (USA), Inc due to Current Good Manufacturing Practice (CGMP) deviations, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.
• Mirabegron is used to treat overactive bladder and neurogenic detrusor overactivity.

The FDA has issued a Class II recall for mirabegron extended-release tablets, 25 mg. This product is manufactured by Zydus Lifesciences, Ltd in India and is being recalled by Zydus Pharmaceuticals (USA), Inc based in Pennington, New Jersey. The recall was initiated on August 5, 2026, and received a Class II classification on August 7, 2026. A Class II classification means the use of this product is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

The recall was initiated due to an N-Nitroso mirabegron impurity, which violates CGMP specifications. This deficiency affects Lot E408618, which will expire in November 2026. Zydus Pharmaceuticals sent out a public notice via letter; no press release has been issued for this recall.

Mirabegron is a prescription medication used to treat symptoms of overactive bladder, including incontinence and frequent urination. It can also be used to treat neurogenic detrusor overactivity. Pharmacists should identify and quarantine Lot E408618, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. August 12, 2026. Accessed August 12, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221880