FDAFDA · Food and drugs·Recall number D-0830-2026
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.
Published September 9, 2026 · Recall initiated: August 26, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MYCOPHENOLATE MOFETIL
- Manufacturer
- Mylan Pharmaceuticals Inc
- Distributor
- U.S. Nationwide
- Lot
- Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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