Class II · Moderate risk
Mitomycin/Mannitol
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Is Mitomycin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Mitomycin (39 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Mitomycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Mitomycin recalls on record
none so far in 2026; 39 on record, newest first
Class II · Moderate risk
Mitomycin C
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 40mg Compounded
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 40mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 2ml
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 20mg
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 0.02%
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Class II · Moderate risk
Mitomycin 0.3 mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Mitomycin (modified)
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Mitomycin 0.04% solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class I · High risk
Mitosol (mitomycin for solution)
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Class II · Moderate risk
Mitomycin/Lidocaine/Epinephrine 0.04%/0.02%/0.1% Injectable 5 Ml
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Mitomycin/Bupivacaine With Epi 1:200
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Class II · Moderate risk
Mitomycin 1mg/Ml Solution 160 Ml …
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
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