The recall affects mirabegron extended-release tablets, 25 milligrams, packaged in 30-count bottles. The affected lot is E408618, with an expiration date of Nov. 30, 2026, and National Drug Code 70710-1159-3.
Zydus began the voluntary recall in early August and notified customers by letter, according to the FDA. The agency classified the recall as Class II, indicating that use of the product may cause temporary or reversible health consequences, with the risk of serious harm considered remote.
The recalled tablets are peach-colored, oval-shaped, and marked “1159” on one side. They were manufactured by Zydus Lifesciences in Ahmedabad, India. The medication was distributed in the United States by Zydus Pharmaceuticals, based in Pennington, New Jersey.
The FDA said the recall was also related to a current good manufacturing practice violation, with the found N-nitroso mirabegron at levels outside quality specifications.
According to the FDA, nitrosamines can enter medications in several ways. They may form during the manufacturing process, result from a drug’s chemical structure, or develop under certain packaging and storage conditions.
“Manufacturers are responsible for understanding their processes, which includes preventing the presence of unacceptable impurities,” according to the FDA, adding that: "Manufacturers are also responsible for developing and using suitable methods to detect and limit unacceptable impurities, including any new impurities that may arise when they make changes to their manufacturing processes."
The FDA urges patients to first consult a health care professional before stopping their medication. Anyone with the recalled medication should also contact their pharmacy or prescriber for guidance. Patients can also ask their pharmacist to confirm the lot number if it is not visible on the prescription bottle.
Adverse reactions can be reported to Zydus at 1-877-993-8779 or through the FDA’s MedWatch program.