FDA reminds compounders not to use dietary supplement grade glutathione for injectables

 [8/27/2026] FDA is aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients.

The glutathione was compounded by different compounding pharmacies, all of which obtained their glutathione (Lot #229536) from Medisca Inc., U.S. headquarters in Plattsburgh, N.Y. The glutathione was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs.

FDA is aware of two pharmacies located in Texas that have conducted recalls related to elevated endotoxin levels in their glutathione injectable drugs.

Reported adverse events included fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, with some resulting in hospitalizations. These symptoms are consistent with exposure to excessive endotoxin levels. Endotoxin exposure also can cause myalgia (muscle pain), headache, nausea, vomiting, hypotension (low blood pressure) and death. However, not all these symptoms have been reported in association with these glutathione adverse events.

Medisca informed the agency on August 20, 2026, that it sent its U.S. customers a warning not to use its dietary supplement grade glutathione in the compounding of injectable drugs. The agency urges compounders that received dietary supplement grade glutathione from Medisca to contact their customers and instruct them to discontinue use of the IV glutathione product.

FDA continues to receive reports of adverse events consistent with endotoxin exposure and is actively investigating. The agency will provide updates as additional information becomes available.

What compounders should know

• Compounders are responsible for ensuring all components used in injectable drugs are appropriate for their intended use and should not use dietary supplement grade ingredients when making injectable drugs.
• Ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that may be harmful when administered as an injectable drug.
• FDA urges compounders to know their bulk drug substance, or active pharmaceutical ingredient (API) and excipient suppliers and ensure all ingredients they use to produce injectable drugs are manufactured under conditions and specifications appropriate for the intended route of administration.
• Compounders should not rely on testing alone to ensure the quality of the drug. Quality should be built into every step of the compounding process, including ingredient sourcing, stock solution preparation and finished drug release.

FDA previously communicated in 2019 about the use of dietary ingredient glutathione for compounding injectable drugs and the agency remains concerned about continued risks to patients.

FDA recommendations

• Health care professionals should check with their compounders regarding the source of the glutathione used to make injectable drugs for their patients.
• API suppliers, relabelers and repackagers should clearly identify the upstream manufacturer of all APIs on labels and certificate of analyses (COAs) and include explicit statements regarding the appropriate and inappropriate uses of each ingredient.
• Consumers who have concerns should talk to their health care professionals.

Reporting adverse events

FDA encourages consumers, health care professionals and compounders to report adverse events or quality problems experienced with the use of compounded drugs to FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at MedWatch: The FDA Safety Information and Adverse Event Reporting Program or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.