Mirabegron Extended-Release Tablets recall (Zydus Pharmaceuticals (USA) Inc)
DrugClass IIOngoing
Summary: Zydus Pharmaceuticals (USA) Inc is recalling 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.. Reason: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What is 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.
Why
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0745-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 5, 2026 |
| Reported | August 12, 2026 |
| Company | Zydus Pharmaceuticals (USA) Inc |
| Company location | Pennington, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from Zydus Pharmaceuticals (USA) Inc · all drug recalls · recalls from August 2026