Mitomycin-c recalls

The FDA has published 3 recalls involving Mitomycin-c since 2022. The latest was reported on 2 Feb 2022. Most were for sterility. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls3since 2022

Last 12 months0reported

Class I00% of total

Ongoing0latest 2 Feb 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 3 100%Class III 0 0%

Why mitomycin-c is recalled

Sterility3100%

Companies

Edge Pharma3100%

By year

20223100%

All mitomycin-c recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
2 Feb 2022Drug	CLASS II	Mitomycin-C, 40mg/ (1mg/mL) per syringe recalled by Edge Pharma	Edge Pharma	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free recalled	Edge Pharma	Sterility	Nationwide
2 Feb 2022Drug	CLASS II	Mitomycin-C Sterile Ophthalmic Solution, Preservative Free recalled	Edge Pharma	Sterility	Nationwide

Should you stop taking Mitomycin-c?

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.