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Class II · ModerateActive recall

Mycophenolate Mofetil

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: 3242616, Exp. April 2027; 8220216, Exp. Nov 2027
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameMYCOPHENOLATE MOFETIL
Generic nameMYCOPHENOLATE MOFETIL
Active ingredient(s)MYCOPHENOLATE MOFETIL
Distributed by / forMylan Institutional LLC, Morgantown, WV 26505, Made in India
NDC67457-386-81
Show the full FDA record
Full product labelCarton 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.
Recalling firmMylan Pharmaceuticals Inc
DistributionU.S. Nationwide
Quantity11,336 units
Recall initiated2026-08-26
Report date2026-09-09
Recall completed—
Recall numberD-0830-2026
ClassificationClass II
FDA statusOngoing
Origin on fileMorgantown WV United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.