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.
Class II · Ongoing
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
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Affected lots / codes — check yours against thisLot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Classification
- Class II (temporary or reversible harm possible)
- Status
- Ongoing
- Quantity
- —
- Distribution
- Nationwide in the USA
- Recall initiated
- August 5, 2026
- Classified
- August 7, 2026
- Initiation
- Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA
enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0745-2026%22
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0745-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots
above against your own product. This page reproduces public FDA data for readability;
EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →