Mirabegron Extended-Release Tablets — Class II drug recall D-0745-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2026-08-12, distributed nationwide. CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
| Recall number | D-0745-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2026-08-05 |
| Classified | 2026-08-07 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 70710-1159, 70710-1159-01, 70710-1159-03, 70710-1159-09, 70710-1160, 70710-1160-01, 70710-1160-03, 70710-1160-09 |
| Lot numbers | E408618 |
| Expiration dates | 2026-11-30 |
Product
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 for recall
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0745-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.