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 |
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.
How to identify the recalled item
| Lot / date codes | Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 |
|---|---|
| Lot / date codes | Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Zydus Pharmaceuticals (USA) Inc recalls
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.