Class I · High risk
Glutathione 200 mg/mL
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Is Glutathione recalled?
New recalls announced
announced by the firm and posted by FDA; not yet in FDA’s classified recall data
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Glutathione Injection
· Greenwich Rx ·
Reason Potential elevated endotoxin levels -
Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial
· Centric Compounding LLC ·
Reason Elevated Endotoxin level
Yes — there is an active recall. 8 ongoing FDA recalls mention Glutathione (79 total). Check the affected lots below.
Most common reason: Sterility / contamination (63 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Glutathione. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Glutathione recalls in 2026
2 initiated in 2026, 79 in total — newest first
Class I · High risk
Glutathione
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Class II · Moderate risk
Glutathione Preserved for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione L Reduced 100mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL…
Lack of assurance of sterility.
Class II · Moderate risk
Glutathione 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/mL Preservative Free
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Glutathione Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 30 mL Vial-For IM Use-Hypertonic solution
Lack of Assurance of Sterility
Class II · Moderate risk
S-Glutathione 200mg/Ml Mdv
Lack of Assurance of Sterility
Class II · Moderate risk
S-Glutathione 200mg/3ml
Lack of Assurance of Sterility
Class II · Moderate risk
S-Ascorbic/Glutathione 1.25/1.25% Opth Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 100 mg/mL Inhalation Solution
Lack of Assurance of Sterility.
Class II · Moderate risk
Glutathione 200mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL…
Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Glutathione liquid
Lack of sterility assurance.
Class II · Moderate risk
Glutathione Injection
Lack of sterility assurance.
Class II · Moderate risk
Glutathione 200 mg/mL Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Glutathione 200mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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