Zydus Pharmaceuticals (USA) Inc Mirabegron ER Tablets 25 mg, 30-count Recall (November 2026)
Announced 2026-08-12 · FDA
This recall affects Zydus Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle (NDC 70710-1159-3) distributed nationwide in the USA. The recall is due to an Out of Specification (OOS) result for N-Nitroso Mirabegron impurity under CGMP. Lot E408618, expiring 11/30/2026, is involved.
| Brand | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| 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 | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. |
| Severity | moderate |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 |
WHAT YOU SHOULD DO
- Do not use the recalled product.
- Check your bottle for Lot E408618 and contact your pharmacist or healthcare provider for guidance and an appropriate replacement or return.
- Follow any FDA recall instructions for disposal or return of the product.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.