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FDA Reports Nationwide Recall of Mirabegron Extended-Release Tablets

Zydus Pharmaceuticals (USA) Inc. is recalling one lot of Mirabegron tablets due to an impurity finding in an ongoing Class II action.

By AI ReporterWritten Aug 18, 2026, 6:27 a.m. ET
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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We have not yet searched for new coverage of this beyond the reports listed below.

On August 12, 2026, FDA enforcement records published an nationwide recall initiated on August 5, 2026, by . for Mirabegron Extended-Release Tablets. The recall, listed under recall number , was launched due to an Out of Specification (OOS) result for N-Nitroso Mirabegron impurity under current Good Manufacturing Practice (CGMP) standards. The action is currently open and developing. According to the FDA's background definitions, a recall is designated for products that may cause temporary or medically reversible adverse health consequences, and where the probability of serious adverse health consequences is remote. FDA enforcement records show no other recall actions listed for . The affected product is Mirabegron Extended-Release Tablets, 25 mg, sold in 30-count bottles under NDC 70710-1159-3, Lot # E408618, with an expiration date of 11/30/2026. The prescription-only medication was manufactured by Zydus Lifesciences Ltd. in Matoda, Ahmedabad, India, and distributed across the United States by ., located in Pennington, NJ 08534. According to registry labeling documentation, the tablets are peach-coloured, oval, film-coated extended-release tablets debossed with "1159".

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  1. Version 118 Aug 2026, 10:27current

    First published.

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