Mycophenolate Mofetil for Injection
Mylan recalls Mycophenolate Mofetil for injection, 500 mg/vial, over failed dissolution specs.
Consumers with affected product should stop using it immediately and contact their healthcare provider or pharmacist for guidance. Return the product to the place of purchase for a refund or replacement.
Recall at a glance
- Quantity recalled
- 11,336 units
Why it was recalled
Mylan Institutional LLC is recalling Mycophenolate Mofetil for injection, USP, 500 mg/vial, due to failed dissolution specifications. The recall affects cartons containing 4 single-dose vials and individual single-dose vials.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
Carton label: Mycophenolate Mofetil for injection, USP
- Lot code
- 3242616, 2027
- Strength
- 500 mg
- NDC / UPC
- NDC 67457-386-81, NDC 67457-386-00
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Dissolution Failure recalls
Other recent recalls from MYLAN PHARMACEUTICALS INC
Editorial summary by Recall Canary · summary updated 2026-09-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification