Mitosol Ophthalmic Solution (Mobius) – Contamination Risk (2013)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Mobius Therapeutics LLC
Lot Codes / Batch Numbers
Lot #: M086920 and M098260, Exp. 08/2013
Products Sold
Lot #: M086920 and M098260, Exp. 08/2013
Mobius Therapeutics LLC is recalling Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per due to Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026