A specific batch of mirabegron, a prescription medication used to treat overactive bladder, is under a nationwide recall in the United States.
The affected product is a 25-milligram extended-release tablet manufactured by Zydus Lifesciences.
The recall concerns a single identified lot after testing found an impurity in the active ingredient that did not meet specifications.
The U.S. Food and Drug Administration (FDA) classifies the recall as Class II, a designation associated with temporary or medically reversible health effects.
Patients who have the affected medication should check the bottle carefully before taking another dose and contact their pharmacy.
The specific lot, National Drug Code and expiration date provide the fastest way to determine whether a bottle is involved.
Which Mirabegron Tablets Are Affected
The FDA recall applies to 25-milligram mirabegron extended-release tablets supplied in bottles containing 30 tablets. The medication was manufactured by Zydus Lifesciences and distributed for use in the United States. According to the recall information reported by EatingWell on August 12, 2026, the affected bottles carry the lot code E408618. The product has an NDC of 70710-1159-3 and an expiration date of November 30, 2026. These identifiers matter because the recall does not mean that every mirabegron product on the market is affected. Patients taking a different strength, a different lot or a different product should not assume that their medication is included based solely on the drug name.
The recall was triggered by an out-of-specification test result involving the active ingredient mirabegron. In practical terms, testing identified an impurity at a level or under conditions that did not satisfy the applicable specifications for the ingredient. The information available from the report does not indicate that every tablet in the affected lot contains a harmful concentration of the impurity. Instead, the recall removes the identified product from the supply chain while the issue is addressed. Patients therefore need to compare the details printed on their own prescription bottle with the recall identifiers rather than stopping every mirabegron prescription automatically.
Mirabegron is prescribed to adults with symptoms associated with overactive bladder, including urinary urgency, increased frequency and urge urinary incontinence. It belongs to a class of medicines that works on beta-3 adrenergic receptors in the bladder, helping the bladder muscle relax during the storage phase of urination. Because patients may rely on the medication to manage persistent symptoms, replacing a recalled supply can require coordination with a pharmacist or prescriber. Anyone who discovers the affected lot should contact the pharmacy that dispensed it and ask what replacement options are available.
There's a nationwide recall on mirabegron tablets due to an impurity. https://t.co/1hDCqdZ21a
— EatingWell Magazine (@EatingWell) August 12, 2026
What The FDA Recall Classification Means
The FDA is the federal agency responsible for overseeing the safety of FDA-regulated drugs and for monitoring recalls involving products that may present a health risk. Its recall system assigns products a classification based on the potential severity of the health hazard. The agency describes a Class II recall as a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. That designation is different from a Class I recall, which is reserved for situations involving a reasonable probability of serious injury or death.
The FDA’s public recall system also notes that not every recall necessarily appears as a standalone press release on its main recalls page. The agency maintains a broader database covering FDA-regulated products and publishes recall information through its enforcement and safety systems. The current FDA recall database is updated with drug recalls alongside recalls involving food, medical devices, cosmetics and other regulated products. The mirabegron information reported by EatingWell identifies the FDA as the federal authority associated with the nationwide recall and gives consumers the agency’s contact number, 1-888-INFO-FDA (1-888-463-6332), for questions.
The Class II designation should not be interpreted as proof that an individual patient will become sick after taking the recalled tablets. It indicates how the agency assesses the potential health hazard associated with the recalled product. The recall itself is a precautionary action intended to remove the identified lot from distribution and prevent further use while the problem is addressed. Patients who have taken tablets from the affected lot and feel well should not assume that symptoms will necessarily develop, while people experiencing concerning symptoms should seek medical advice rather than trying to determine the cause themselves.
