Why it was recalled
Failed Dissolution Specifications
Product description
Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
Lot numbers, UPCs & expiration codes
Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
Where it was sold
U.S. 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-0830-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 26, 2026
- FDA report date
- Sep 9, 2026
- Quantity
- 11,336 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0830-2026, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Ongoing
- Country
- United States
- Event ID
- 99750
- Address
- 3711 Collins Ferry Rd
- Code information
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Postal code
- 26505-2362
- Report date
- Sep 9, 2026
- Product type
- Drugs
- Recall number
- D-0830-2026
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc
- Product quantity
- 11,336 units
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, Single Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-00.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Aug 26, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 3, 2026