Mirabegron Extended-Release Tablets 25 mg
Zydus recalls Mirabegron ER 25 mg tablets over nitrosamine impurity.
Consumers should stop taking the recalled tablets and contact their healthcare provider for guidance. Return the product to the place of purchase for a refund or contact Zydus Pharmaceuticals for further instructions.
Why it was recalled
Zydus Pharmaceuticals is recalling Mirabegron Extended-Release Tablets, 25 mg, 30-count bottles, due to an out-of-specification result for the N-Nitroso Mirabegron impurity, a potential nitrosamine impurity.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Mirabegron Extended-Release Tablets
- Lot code
- E408618, 2026, 70710-1159-3
- Strength
- 25 mg
- NDC / UPC
- NDC 70710-1159-3
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Impurity or Degradation recalls
Other recent recalls from Zydus Pharmaceuticals (USA) Inc
Editorial summary by Recall Canary · summary updated 2026-08-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification