FDA-Drug2026-09-09Class IICHEMICAL
Mylan Mycophenolate Mofetil injection recalled for failed dissolution specifications
What this means
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.
- 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.
The agency's original wording
Hazard
Failed Dissolution Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
11,336 units
Manufactured in
3711 Collins Ferry Rd, N/A, Morgantown, WV, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0830-2026Want us to check the next one for you?
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