United StatesMirabegron Extended‑Release Tablets, 25 mg, 30‑count bottles (NDC 70710-1159-3), lot E408618, expiry 11/30/2026, manufactured by Zydus Lifesciences Ltd. and distributed by Zydus Pharmaceuticals (USA) Inc., sold nationwide in the United States, are affected. The product was recalled due to an out-of-specification result for the N‑Nitroso Mirabegron impurity related to CGMP.
What's being recalled
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.
Recalling firm: Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States.
How to identify it
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
The hazard
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide in the USA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)