Mitomycin recalls
The FDA has published 24 recalls involving Mitomycin since 2012. The latest was reported on 1 Feb 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 recalls 24 since 2012
Last 12 months 0 reported
Class I 1 4% of total
Ongoing 1 latest 1 Feb 2023
Recalls per month, last 24 months click a bar for that month Severity split
1 4%23 96%0 0%
Why mitomycin is recalled
Ongoing mitomycin recalls 1 active
All mitomycin recalls, newest first 24 total Reported Class Recall Company Reason Where 1 Feb 2023 Drug CLASS II Mitomycin 0.2mg/ML Droptainer) Oph Solution recalled Pharmacy Innovations Sterility Nationwide 1 Feb 2023 Drug CLASS II Mitomycin 0.4mg/ML Droptainer) Oph Solution recalled Pharmacy Innovations Sterility Nationwide 18 Jan 2023 Drug CLASS II Mitomycin Injection Solution, 4mg/ml recalled Northern VA Compounders Pllc Sterility Nationwide 9 Nov 2022 Drug CLASS II Mitomycin Injection 0.375 mg/mL Syr, 0.375 mg/mL solution syringe recalled Pharmacy Plus Sterility 4 states 21 Aug 2019 Drug CLASS II Mitomycin 10 MG / Ivp Syringe recalled by Infusion Options Infusion Options Sterility NY 7 Feb 2018 Drug CLASS II Mitomycin 40 mg/mL Preservative Free Irrigation Volume recalled Premier Pharmacy Labs Other Nationwide 11 Jan 2017 Drug CLASS II Mitomycin 20 mg Injectable, Lyophilized (Buffered) vial recalled Wells Pharmacy Network Sterility Nationwide 11 Jan 2017 Drug CLASS II Mitomycin Solution Injectable, Sterile recalled Wells Pharmacy Network Sterility Nationwide 11 Jan 2017 Drug CLASS II Mitomycin Solution Injectable, Sterile recalled Wells Pharmacy Network Sterility Nationwide 11 Jan 2017 Drug CLASS II Mitomycin 40 mg Injectable, Lyophilized (Buffered) vial recalled Wells Pharmacy Network Sterility Nationwide 19 Oct 2016 Drug CLASS II Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection recalled Leiter's Compounding Sterility Nationwide 23 Sep 2015 Drug CLASS II Mitomycin 0.02% Ophthalmic Solution, single dose dropper recalled The Compounding Pharmacy of America Sterility Nationwide 23 Sep 2015 Drug CLASS II Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper recalled The Compounding Pharmacy of America Sterility Nationwide 23 Sep 2015 Drug CLASS II Mitomycin 40 mg/ Sodium Chloride 0.9% Injection recalled The Compounding Pharmacy of America Sterility Nationwide 23 Sep 2015 Drug CLASS II Mitomycin 40 mg/ Sodium Chloride 0.9% Injection recalled The Compounding Pharmacy of America Sterility Nationwide 12 Nov 2014 Drug CLASS II Mitomycin, 0.2mg/mL, injectable glass vial, RX recalled Oregon Compounding Centers Sterility OR, WA 12 Nov 2014 Drug CLASS II Mitomycin, 0.3mg/mL, injectable glass vial, RX recalled Oregon Compounding Centers Sterility OR, WA 11 Dec 2013 Drug CLASS II Mitomycin 40mg, Main Street Compounding Pharmacy recalled Main Street Family Pharmacy Other Nationwide 11 Dec 2013 Drug CLASS II Mitomycin 20mg, Main Street Compounding Pharmacy recalled Main Street Family Pharmacy Other Nationwide 31 Jul 2013 Drug CLASS I Mitosol (mitomycin for solution), 0.2 mg/vial, Kit recalled Mitosol Mobius Therapeutics Mold Nationwide 10 Jul 2013 Drug CLASS II Mitomycin 0.04% solution, Clinical Specialties Compounding recalled Clinical Specialties Compounding Pharmacy Sterility FL, GA, SC 12 Jun 2013 Drug CLASS II Mitomycin 0.3 mg/mL Injectable vials recalled by The Compounding Shop The Compounding Shop Sterility 4 states 22 Aug 2012 Drug CLASS II Mitomycin/lidocaine/epinephrine 0.04%/0.02%/0.1% Injectable recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility Nationwide 22 Aug 2012 Drug CLASS II Mitomycin 1mg/ML Solution recalled by Franck's Lab Inc., d.b.a. Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility 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.