Mycophenolate Mofetil for Injection USP recall (MYLAN PHARMACEUTICALS INC)
DrugClass IIOngoing
Summary: MYLAN PHARMACEUTICALS INC is recalling Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).. Reason: Presence of precipitate.
What is being recalled
Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 vials per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV, 26505 USA, Made in India, NDC 67457-386-00 (vial label) & NDC 67457-386-81 (carton label).
Why
Presence of precipitate
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
USA Nationwide
How to tell if yours is affected
Lot #: 3241653, Exp 4/30/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0734-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 2, 2026 |
| Reported | August 5, 2026 |
| Company | MYLAN PHARMACEUTICALS INC |
| Company location | Morgantown, WV, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5688 vials |
More recalls from MYLAN PHARMACEUTICALS INC · all drug recalls · recalls from July 2026