FDA recall, , Moderate risk
Mylan Mycophenolate Mofetil for Injection
Mycophenolate Mofetil for injection fails dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
Mylan Pharmaceuticals Inc., based in Morgantown, West Virginia, recalled Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, because it failed dissolution specifications. The recall began August 26, 2026, and was added to the FDA's Enforcement Report on September 3, 2026. The product was distributed nationwide in the U.S.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Mycophenolate Mofetil for injection, USP, 500 mg/vial
- NDC
- 67457-386-81
- 67457-386-00
- Lot code
- 3242616
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- MYLAN PHARMACEUTICALS INCMorgantown, West Virginia
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99750
- Recall number
- D-0830-2026
- Quantity recalled
- 11,336 units
All recalls from MYLAN PHARMACEUTICALS INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
