Mycophenolate Mofetil recalls

The FDA has published 4 recalls involving Mycophenolate Mofetil since 2019. The latest was reported on 9 Sep 2026. Mylan Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2019
Last 12 months2reported
Class I125% of total
Ongoing2latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 1 25%Class II 2 50%Class III 1 25%

Why mycophenolate mofetil is recalled

Companies

By year

Ongoing mycophenolate mofetil recalls

2 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IICarton label: Mycophenolate Mofetil for injection recalledMycophenolate MofetilMylan PharmaceuticalsSterilityNationwide
DrugCLASS IIMycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate MofetilMylan PharmaceuticalsOtherNationwide

All mycophenolate mofetil recalls, newest first

4 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IICarton label: Mycophenolate Mofetil for injection recalledMycophenolate MofetilMylan PharmaceuticalsSterilityNationwide
DrugCLASS IIMycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate MofetilMylan PharmaceuticalsOtherNationwide
DrugCLASS IIIMycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalledMycophenolate MofetilVistaPharmOtherNationwide
DrugCLASS IMycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate MofetilPar PharmaceuticalParticulate MatterNationwide

Should you stop taking Mycophenolate Mofetil?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.