Mirabegron Extended-Release Tablets, 25 mg, 30-count… was recalled on August 5, 2026 in cooperation with the U.S. Food and Drug Administration because CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity..
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Zydus Pharmaceuticals (USA) Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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