# FDA drug recall: Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, 

> recall · VERIFIED · 2026-08-05

Firm: Zydus Pharmaceuticals (USA) Inc · Class II · CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.

- Company: Zydus Pharmaceuticals (USA) Inc
- Sector: therapeutics
- Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Source: MedFuel Intel news monitor. Verification tier: VERIFIED. Informational only, not investment advice. Corrections: media@medfuelinc.com.