Class II · ModerateActive recall
Mirabegron
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # E408618, Expiry: 11/30/2026, NDC #: [redacted-phone]-3
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byZydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 foreign manufacturer
| Brand name | MIRABEGRON |
| Generic name | MIRABEGRON |
| Active ingredient(s) | MIRABEGRON |
| Distributed by / for | Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534 |
| NDC | 70710-1159-3 |
Show the full FDA record
| Full product label | 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 |
| Distribution | Nationwide in the USA |
| Recall initiated | 2026-08-05 |
| Report date | 2026-08-12 |
| Recall completed | — |
| Recall number | D-0745-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Pennington NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.