The U.S. Food and Drug Administration has issued a nationwide recall for specific batches of mirabegron extended-release tablets. This medication is commonly prescribed to treat symptoms related to overactive bladder. The recall action stems from identified impurities in the active ingredient found during laboratory testing.
Zydus Lifesciences is the manufacturer responsible for the affected product. The recall focuses on 25-milligram tablets packaged in 30-count bottles. Patients should inspect their medication bottles for the following specific details: lot code E408618, NDC 70710-1159-3, and an expiration date of 11/30/2026. These identifiers are printed on the product label.
This action is categorized as a Class II recall. The FDA defines this classification as a situation where use of the product may lead to temporary or medically reversible health effects. While the risks are considered reversible, the agency urges patients to verify their current prescription supplies against these details immediately.
Individuals who possess the affected bottles should stop using them and contact their pharmacy to arrange for a return, refund, or replacement. If you have already consumed these tablets and are concerned about your health, consult a physician or healthcare provider promptly. For further information or to report adverse reactions, you may reach the FDA directly by calling 1-888-463-6332.