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.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
| Recalling firm | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| Reason | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 12, 2026 |
| Initiated | Aug 5, 2026 |
| Region | NJ, United States |
| Distribution | Nationwide in the USA |
| Code/Lot | Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3 |
| Type | Voluntary: Firm initiated |
| Recall number | D-0745-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: D-0745-2026)
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