Mitomycin recalls

The FDA has published 5 recalls involving Mitomycin since 2013. The latest was reported on 18 Jan 2023. Most were for sterility. Wells Pharmacy Network 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 recalls5since 2013

Last 12 months0reported

Class I120% of total

Ongoing1latest 18 Jan 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 20%Class II 4 80%Class III 0 0%

Why mitomycin is recalled

Sterility480%
Mold120%

Companies

By year

2023120%
2022120%
2017240%
2013120%

Ongoing mitomycin recalls

1 active

Reported	Class	Recall	Company	Reason	Where
9 Nov 2022Drug	CLASS II	Mitomycin Injection 375 mg/mL Syr, 375 mg/mL solution syringe recalled	Pharmacy Plus	Sterility	4 states

All mitomycin recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
18 Jan 2023Drug	CLASS II	Mitomycin Injection Solution, 4mg/ml recalled	Northern VA Compounders P	Sterility	Nationwide
9 Nov 2022Drug	CLASS II	Mitomycin Injection 375 mg/mL Syr, 375 mg/mL solution syringe recalled	Pharmacy Plus	Sterility	4 states
11 Jan 2017Drug	CLASS II	Mitomycin Solution Injectable, Sterile recalled	Wells Pharmacy Network	Sterility	Nationwide
11 Jan 2017Drug	CLASS II	Mitomycin Solution Injectable, Sterile recalled	Wells Pharmacy Network	Sterility	Nationwide
31 Jul 2013Drug	CLASS I	Mitosol (mitomycin for solution), 2 mg/vial, Kit recalledMitosol	Mobius Therapeutics	Mold	Nationwide

Should you stop taking Mitomycin?

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.