CLASS IIONGOINGDrug recall · Reported 15 Oct 2025 · FDA Enforcement Report
Glutathione Preserved for Injection, all strengths recalled by GenoGenix
GenoGenix is recalling Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840, distributed nationwide in the US. The recall was initiated on 30 Jul 2025 and the FDA has classified it as Class II.
Check your package
Lot, batch or date codesAll lots within expiry.
Quantity recalled907
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.
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Glutathione Preserved for Injection, all strengths and presentations, GenoGenix LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.