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Mycophenolate Mofetil for Injection
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DRUG RECALLMODERATE

Mycophenolate Mofetil for Injection

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

What to do

Consumers who have the affected product should stop using it immediately and contact their healthcare provider or pharmacist for guidance. Return the product to the place of purchase or contact Mylan Pharmaceuticals for further instructions.

Recalled
Listed
Updated
Recall No.
D-0734-2026
Agency
FDA
Firm
MYLAN PHARMACEUTICALS INC
Recall ID
99364
Status
ONGOING

Recall at a glance

Quantity recalled
5688 vials

Why it was recalled

Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for Injection USP, 500 mg/vial single-dose vials, due to the presence of precipitate. The affected product is used as an immunosuppressant and was distributed in the U.S.

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

Lot code
3241653, 2027
Strength
500 mg
NDC / UPC
NDC 67457-386-00, NDC 67457-386-81

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification