FDAHealthAugust 5, 2026
Zydus Pharmaceuticals (USA) Inc — Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharma
⚠️ CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 5, 2026
Nationwide in the USA
What's affected?
- 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.
- Brand
- MIRABEGRON
- Lot code
- E408618
Additional details
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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