Why it was recalled
Presence of precipitate
Product description
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).
Lot numbers, UPCs & expiration codes
Lot #: 3241653, Exp 4/30/2027
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0734-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 2, 2026
- FDA report date
- Aug 5, 2026
- Quantity
- 5688 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- MYLAN PHARMACEUTICALS INC
Original FDA data
Every field from FDA enforcement report D-0734-2026, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 99364
- Address
- 1311 Pineview Dr
- Code information
- Lot #: 3241653, Exp 4/30/2027
- Postal code
- 26505-3276
- Report date
- Aug 5, 2026
- Product type
- Drugs
- Recall number
- D-0734-2026
- Classification
- Class II
- Recalling firm
- MYLAN PHARMACEUTICALS INC
- Product quantity
- 5688 vials
- Reason for recall
- Presence of precipitate
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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).
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jul 2, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2026