Mylan Pharmaceuticals Inc: Mycophenolate Mofetil For Injection Usp, 500 Mg/vial, Single Dose Vial, 4 Vials Per Carton

Recall Summary Mylan Pharmaceuticals is recalling Mycophenolate Mofetil for Injection USP (500 mg vials) distributed nationwide because the medication contains precipitate, or solid particles suspended in the liquid. This is a Class II recall, meaning use of the affected product could cause serious health problems or death. The recalled product was distributed across all U.S. states and Washington, D.C.

Recalling firm
MYLAN PHARMACEUTICALS INC
Product
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
Classification
Class II
Category
drug recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-07-02
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/236a08cb-2774-4319-8261-bad2cb1563c5