FDA recall, , Moderate risk
Mylan Mycophenolate Mofetil for Injection
Mycophenolate Mofetil for Injection USP contains a precipitate.
Summary by Recall Canary from the FDA notice
What happened
Mylan Pharmaceuticals Inc. recalled Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, because the product contains a precipitate. The recall began on July 2, 2026, and was added to the FDA's Enforcement Report on July 24, 2026. The product was distributed nationwide in the USA.
The recalled product is manufactured for Mylan Institutional LLC, Morgantown, WV, 26505 USA, and made in India. The recall involved 5,688 vials.
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
- NDC
- 67457-386-00
- 67457-386-81
- Lot code
- 3241653
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- MYLAN PHARMACEUTICALS INCMorgantown, West Virginia
- Hazard
- Quality 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
- 99364
- Recall number
- D-0734-2026
- Quantity recalled
- 5688 vials
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
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
