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.
FDA recall notice · announced August 5, 2026 · Mylan Pharmaceuticals
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The 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.
Reason for recall
Presence of precipitate
Notes
Distribution: USA Nationwide
Lot/code information: Lot #: 3241653, Exp 4/30/2027
Quantity: 5688 vials
Status: Ongoing
Products in this recall event:
- 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- (D-0734-2026)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.