CLASS I Drug recall · Reported 31 Jul 2013 · FDA Enforcement Report
Mitosol (mitomycin for solution), 2 mg/vial, Kit recalled
Mobius Therapeutics is recalling Mitosol (mitomycin for solution), 2 mg/vial, Kit for Ophthalmic Use (, distributed nationwide in the US. The recall was initiated on 3 Jan 2013 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-809-2013
- FDA event ID
- 64018
- Recalling firm
- Mobius Therapeutics, Saint Louis, MO
- Brand
- Mitosol
- Manufacturer
- Mobius Therapeutics LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Jan 2013
- FDA classified
- 19 Jul 2013
- Reported
- 31 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Mold
- Drug class
- Eye Drops
Timeline
| 3 Jan 2013 | Recall initiated by company | |
| 19 Jul 2013 | Classified by FDA | +197 days |
| 31 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Product as listed by the FDA
Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.
Where it was distributed
Nationwide and Military and Government Consignees
Questions about this recall
Is Mitosol (mitomycin for solution), 2 mg/vial, Kit for Ophthalmic Use ( recalled?
Yes. Mobius Therapeutics recalled Mitosol (mitomycin for solution), 2 mg/vial, Kit for Ophthalmic Use ( on 3 Jan 2013. The recall is Class I and its status is Terminated. Recall number D-809-2013.
Why was it recalled?
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Which lots are affected?
Lot #: M086920 and M098260, Exp. 08/2013
Where was it sold?
Nationwide and Military and Government Consignees
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Mitomycin recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mitomycin Injection Solution, 4mg/ml recalled | Northern VA Compounders P | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Injection 375 mg/mL Syr, 375 mg/mL solution syringe recalled | Pharmacy Plus | Sterility | 4 states |
| Drug | CLASS II | Mitomycin Solution Injectable, Sterile recalled | Wells Pharmacy Network | Sterility | Nationwide |
| Drug | CLASS II | Mitomycin Solution Injectable, Sterile recalled | Wells Pharmacy Network | Sterility | Nationwide |