Mirabegron Recall 2026: FDA Warns of Cancer-Linked Impurity in Bladder Medication

Zydus Pharmaceuticals has recalled one lot of mirabegron 25 mg after testing found elevated N-nitroso mirabegron. Learn about the recall, affected lot, potential risks, and what patients should do.

Mirabegron Recall Raises Questions About Medication Safety

Patients taking prescription medication for overactive bladder should be aware of a nationwide recall involving one lot of mirabegron extended-release tablets, 25 mg.

Zydus Pharmaceuticals is voluntarily recalling a specific lot of the medication after testing identified N-nitroso mirabegron, a type of nitrosamine impurity, at levels above the company's acceptable quality specifications. The recall was reported by the U.S. Food and Drug Administration (FDA), which classified it as a Class II recall.

The classification means that using the recalled product could potentially cause temporary or medically reversible health effects. According to the FDA's assessment, the likelihood of serious adverse health consequences is considered remote.

The recall does not mean that every bottle of mirabegron is affected. It applies specifically to an identified lot of 25 mg extended-release tablets.

Which Mirabegron Product Has Been Recalled?

Patients and caregivers should check their prescription packaging carefully. According to the FDA information provided for the recall, the affected product has the following identifying details:

• Medication: Mirabegron extended-release tablets
• Strength: 25 mg
• Package: 30-count bottle
• Lot number: E408618
• Expiration date: November 30, 2026
• National Drug Code: 70710-1159-3
• Appearance: Peach-colored, oval-shaped tablets
• Tablet marking: “1159” on one side
• Manufacturer: Zydus Lifesciences
• U.S. distributor: Zydus Pharmaceuticals

The recalled medication was manufactured by Zydus Lifesciences in Ahmedabad, India, and distributed in the United States by Zydus Pharmaceuticals, which is based in Pennington, New Jersey.

If a patient cannot find the lot number on their prescription bottle, the pharmacy that dispensed the medication may be able to verify whether the product is included in the recall.

Why Was Mirabegron Recalled?

The central issue involves a chemical impurity known as N-nitroso mirabegron.

Nitrosamines are a group of chemical compounds that can occur in certain medicines. Some nitrosamine impurities have been associated with a potential increased risk of cancer when people are exposed to levels above established safety limits for extended periods.

The FDA explains that nitrosamine impurities can enter medications through several pathways. They can potentially form during manufacturing, arise because of a medication's chemical properties, or develop because of certain packaging and storage conditions.

In this case, federal testing found N-nitroso mirabegron at levels outside the applicable quality specifications. The FDA also cited a current good manufacturing practice issue related to the recalled product.

It is important to put the potential cancer risk into context. The presence of a nitrosamine impurity does not mean that someone who takes the medication will develop cancer. The FDA notes that exposure at or below the acceptable daily intake level every day for 70 years is not expected to increase a person's cancer risk.

What Is Mirabegron Used For?

Mirabegron is a prescription medication commonly used to treat overactive bladder in adults.

Overactive bladder can cause symptoms such as:

• A frequent need to urinate
• Sudden or urgent urges to urinate
• Urine leakage associated with urgency

Mirabegron is also approved for certain children aged 3 and older who have particular nerve-related bladder-control disorders.

The medicine works differently from some other treatments for overactive bladder. It helps relax the bladder muscle, which can allow the bladder to hold more urine and may reduce some symptoms associated with urinary urgency and frequency.

Because patients may rely on mirabegron to manage ongoing bladder symptoms, suddenly stopping treatment without medical advice may create problems. Patients should therefore discuss the recall with their health care professional before making changes to their medication.

Should Patients Stop Taking Recalled Mirabegron?

Patients who believe they have the recalled lot should not automatically stop taking the medication without first speaking with a health care professional.

The FDA advises patients to contact their doctor, prescriber, or pharmacist for guidance. A health care professional can determine whether the medication should be replaced and whether another treatment is appropriate.

A pharmacist can also help confirm whether a patient's prescription matches the recalled lot. This can be particularly useful when the original packaging is unavailable or the lot number is difficult to read.

Patients should not assume that every mirabegron prescription is part of the recall. The notice concerns a specific product lot, so checking the identifying information is important.

What Should Patients Do If They Have the Recalled Product?

If your medication matches the recalled lot, contact your pharmacy or prescribing health professional. Ask what alternative medication or replacement supply is appropriate before making changes to your treatment.

Patients should also monitor for any health concerns and discuss unusual symptoms with a qualified medical professional. Medication decisions should be based on individual circumstances, including other medicines, medical history, and the reason mirabegron was prescribed.

The FDA's MedWatch system can be used to report suspected adverse reactions or other problems associated with medications.

Zydus has also provided a contact number for reports and questions related to the recall: 1-877-993-8779.

Understanding the FDA Class II Recall

The FDA uses recall classifications to describe the potential level of health risk associated with a recalled product.

A Class II recall generally applies when use of, or exposure to, a product could cause temporary or medically reversible adverse health consequences, while the probability of serious harm is considered remote.

That classification provides important context for consumers. A recall is a precautionary regulatory action designed to remove a product that does not meet applicable standards from the market. It does not necessarily indicate that every person who used the product has been harmed or will experience serious health consequences.

The Bottom Line for Mirabegron Users

The 2026 mirabegron recall affects a specific lot of 25 mg extended-release tablets manufactured by Zydus after testing identified N-nitroso mirabegron above acceptable quality limits.

Patients can check their bottle for lot E408618, expiration date November 30, 2026, and NDC 70710-1159-3. Anyone who believes they have the recalled product should contact their pharmacist or health care provider for individualized advice.

Most importantly, patients should not panic or discontinue a prescribed medication on their own. The FDA considers the risk of serious harm from the recalled product to be remote, while appropriate medical guidance can help patients safely transition to an alternative if necessary.

Disclaimer: This article is provided for general informational and educational purposes only. It is not medical advice and does not replace guidance from a physician, pharmacist, or other qualified health care professional. Patients should consult a qualified professional before stopping, changing, or replacing any prescription medication. Recall information can change, so consumers should verify current details with the FDA, their pharmacist, or the medication manufacturer.

Sources: U.S. Food and Drug Administration recall information and medication safety guidance, as well as the prescribing information for mirabegron.