The FDA has issued a nationwide Class II recall for 25 mg mirabegron extended‑release tablets manufactured by Zydus Lifesciences after testing found an impurity in the active ingredient. The recall specifically applies to 30‑count bottles with Lot E408618, NDC 70710-1159-3, and expiration 11/30/2026. Consumers with the affected lot should stop using the product, contact their pharmacy for a refund or replacement, and seek medical care if they experience any symptoms.
FDA Issues Nationwide Class II Recall of Mirabegron 25 mg (30‑Count) — Check Your Medication Now
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The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of a specific mirabegron extended‑release tablet lot after testing identified an impurity in the active ingredient. Patients and pharmacies should check bottles immediately for the affected lot and follow the guidance below.
Affected Product
The recall applies to 25 mg mirabegron extended‑release tablets in 30‑count bottles manufactured by Zydus Lifesciences. The specific product identifiers to check are:
- Lot Code: E408618
- NDC: 70710-1159-3
- Expiration Date: 11/30/2026
Reason for Recall
Out‑of‑specification testing confirmed the presence of an impurity in the active pharmaceutical ingredient, mirabegron. Because this may cause temporary or medically reversible adverse health consequences, the FDA has classified the action as a Class II recall.
What Patients Should Do
If your bottle matches the lot code, NDC, and expiration date above, stop using the product and contact your pharmacy to arrange a refund or replacement. Do not dispose of the product until you have instructions from your pharmacy or the manufacturer. If you are experiencing any symptoms or health concerns after taking the medication, seek medical attention promptly.
If you are unsure whether your medication is affected, contact your prescribing clinician or pharmacist for verification before making changes to your treatment. Do not stop any prescribed medication without first consulting your healthcare provider.
Pharmacies and Health Care Providers
Pharmacies, clinics, and hospitals should review inventory immediately for the specified lot and follow FDA and manufacturer instructions for quarantine and return of recalled product.
More Information
For questions about the recall, consumers and providers may contact the FDA at 1-888-INFO-FDA (1-888-463-6332). For product‑specific guidance, contact the manufacturer or your pharmacy.
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