A common bladder medication has been recalled nationwide due to a carcinogenic impurity, the Food and Drug Administration recently announced.1

Certain bottles of mirabegron, a prescription drug that treats overactive bladders, contain higher-than-acceptable levels of a nitrosamine, an impurity that can raise the risk of cancer over time.

In early August, the FDA designated the recall as the second-highest risk level, Class II. This means the medication may cause temporary or reversible effects, but the risk of serious health issues is low.

Which Bladder Medication Was Recalled?

• Product description: Mirabegron Extended-Release Tablets, 25 mg
• Size: 30-count bottle
• Lot number: E408618
• Expiry date: Nov. 30, 2026
• NDC: 70710-1159-3
• Manufactured by: Zydus Lifesciences

What You Should Do

If your bottle of mirabegron is part of the recall, contact your healthcare provider or pharmacist to determine the best course of action.

Class II recalls can be serious, but stopping a medication suddenly may be riskier, Jennifer Young, PharmD, BCPS, CSP, lead medication safety specialist at the Institute for Safe Medication Practices, previously told HEALTH.

“While recall notifications can be frightening,” she said, “it’s important to contact your healthcare provider right away for advice before making any changes to your medication routine.”