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Mycophenolate Mofetil for Injection
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Mycophenolate Mofetil for Injection

Mylan recalls Mycophenolate Mofetil for Injection 500 mg vials due to precipitate.

What to do

Check your inventory for Mycophenolate Mofetil for Injection USP, 500 mg/Vial, with NDC 67457-386-00. Stop using the affected product and contact Mylan Pharmaceuticals for return and replacement instructions.

Posted
Updated
Agency
FDA
Firm
MYLAN PHARMACEUTICALS INC
Recall ID
99364
Status
ONGOING

Why it was recalled

Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for Injection USP, 500 mg/Vial, due to the presence of precipitate. The product is packaged in single-dose vials, 4 vials per carton, and is used as an immunosuppressant.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Mycophenolate Mofetil for Injection USP

Strength
500 mg
NDC / UPC
NDC 67457-386-00

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · last updated 2026-07-26 · primary source: U.S. Food and Drug Administration