Class II · Moderate risk
Mitomycin Injection Solution
Lack of Assurance of Sterility
Is Mitomycin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Mitomycin (39 total). Check the affected lots below.
Most common reason: Sterility / contamination (30 of these recalls)
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 0.4mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Mitomycin 0.2mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
MITOMYCIN INJECTION 0.375 mg/mL SYR
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
Mitomycin-C
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin-C Sterile Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin-C
Lack of Assurance of Sterility
Class II · Moderate risk
*Mitomycin 0.04% Ophth DR eye drops
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class II · Moderate risk
Mitomycin-C
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin 0.04%
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin Preservative Free Irrigation
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Class II · Moderate risk
Mitomycin 10 Mg /20 Ml Ivp Syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV
Labeling: Label Error on Declared Strength
Class II · Moderate risk
Mitomycin 40 mg Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin 20 mg Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin Solution Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin Solution Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Mitomycin 0.02%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin 0.03% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin 0.02% Ophthalmic Solution
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Mitomycin C active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Mitomycin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Mitomycin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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