Notice names this product. Zydus Pharmaceuticals (USA)’s Mirabegron Extended-Release Tablets is named in FDA Class II recall D-0745-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. Identifying details: Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Company / brand: Zydus Pharmaceuticals (USA)
Affected product: Mirabegron Extended-Release Tablets
Official ID D-0745-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.