The U.S. Food and Drug Administration has issued a nationwide recall for a specific lot of mirabegron extended-release tablets. This medication is commonly prescribed to manage symptoms of overactive bladder. The recall action follows an out-of-specification test result that identified an impurity within the active ingredient.
Zydus Lifesciences, the manufacturer of the affected tablets, initiated the recall for the 25-milligram, 30-count bottles. Patients should identify their medication by checking for the lot code E408618. The affected products also carry an NDC number of 70710-1159-3 and an expiration date of 11/30/2026. These specific details are critical for determining whether a bottle in your possession is part of the safety alert.
This recall is classified as Class II. This designation indicates that the product may cause temporary or reversible adverse health consequences if consumed. It is a precautionary measure meant to protect patients from risks associated with the identified impurity.
If you have these tablets at home, you should contact your pharmacy immediately. They will assist you with a refund or provide a replacement for your prescription. Do not continue to use the product if it matches the recalled lot code. If you have already taken the medication and have concerns about your health, consult your physician.
For additional questions regarding this recall, the FDA encourages the public to contact them directly by calling 1-888-INFO-FDA. Staying informed about your prescriptions is a necessary part of managing personal health. Check your medicine cabinet today to ensure your supply is safe.