Mylan Mycophenolate Mofetil injection recalled for failed dissolution specifications
Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.
From the FDA notice · Read the official notice ↗ · All Mylan recalls
What to do
- If you use this medication, contact your pharmacy or healthcare provider immediately with the lot and expiration date on your vial.
- Do not use vials from lot 3242616 (expires April 2027) or lot 8220216 (expires November 2027).
- Your doctor can provide an alternative or verified replacement.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- Adults
Details
- Units affected
- 11,336 units
- Illnesses reported
- None reported
- Manufactured in
- 3711 Collins Ferry Rd, N/A, Morgantown, WV, United States
- Classification
- Class II
- Recall number
- D-0830-2026
In the FDA's words
- 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. Failed Dissolution Specifications Lot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027 Distribution: U.S. Nationwide Affected quantity: 11,336 units
- Hazard
- Failed Dissolution Specifications
More from Mylan
See all- Mylan Prasugrel 10mg tablets recalled for failed dissolution specifications
ModerateFDASep 9, 2026
- Mylan Acamprosate Calcium tablets recalled for failed dissolution specifications
ModerateFDAAug 26, 2026