Adverse Events Linked to Injectable Glutathione Compounded with Dietary Supplement Grade Ingredient: Current Situation

Summary

CDC has recently received reports of people becoming sick after receiving glutathione injections. The illnesses are likely linked to elevated levels of endotoxins in the injected products. Endotoxins are harmful substances produced by certain types of bacteria. They can contaminate medicines or other products if proper quality controls are not followed. For this reason, glutathione ingredients labeled for dietary use should not be used to compound injectable products.

Exposure to high levels of endotoxins can cause a sudden reaction. Symptoms may include:

• Fever and chills
• Body aches
• Headache
• Nausea
• Dizziness
• Low blood pressure

Reactions can be severe and may require emergency medical care.

Similar illnesses linked to endotoxin-contaminated injectable glutathione have been reported in the past.

Background

Glutathione is an antioxidant that occurs naturally in the body. There are no FDA-approved glutathione products in the United States. In the United States, it is sold as a dietary supplement taken by mouth and promoted for purposes such as skin brightening, immune support, detoxification, and increased energy.

Glutathione injections contaminated with endotoxins have been linked to groups of patients becoming ill in the past. This includes an outbreak in Australia in 20151 and adverse events at a U.S. clinic that led to an FDA safety alert in 20192.

Ingredients labeled as "dietary supplement" or "dietary supplement grade" may contain impurities or contaminants, including endotoxins. These ingredients are not appropriate for use in sterile injectable drugs.

Outbreak summary

In July 2026, the Texas Department of State Health Services notified CDC about a group of patients who became sick after receiving intravenous (IV) glutathione at an outpatient wellness clinic. CDC has been working with state and local health departments to support case-finding, patient outreach, and coordination with the clinics involved.

Since then, CDC has received reports of over 25 people becoming sick in at least four states: Texas, Washington, Florida, and New York. Patients received glutathione intravenously or by injection under the skin or into a muscle.

At least three patients have been hospitalized. All three received glutathione intravenously. One patient became critically ill and required intensive care, including treatment for shock and abnormal blood clotting.

So far, all the glutathione injections linked to these illnesses were made by compounding pharmacies using glutathione ingredients intended for use in dietary supplements. Dietary supplement-grade glutathione should not be used in sterile injectable drugs because of the risk of introducing contaminants, such as endotoxins.

At least three pharmacies in Texas have recalled compounded injectable glutathione products because of high levels of endotoxins345. FDA has also issued a safety alert reminding compounders not to use dietary supplement-grade glutathione to make injectable products6.

The investigation is ongoing. The number of people and states affected may change as more information becomes available.

What CDC recommends

CDC is sharing the following interim recommendations for healthcare providers and clinics, compounding pharmacies, and patients while the investigation continues.

For healthcare providers & clinics that administer injectable glutathione

• Do not administer injectable glutathione products that were compounded using dietary supplement grade ingredients, or products whose ingredient grade cannot be verified with the compounding pharmacy.
• Confirm with your compounding pharmacy that the ingredient used in any injectable glutathione product you administer is appropriate for the intended route of administration and was not compounded from a dietary supplement or dietary supplement grade ingredient.
• Be aware of the recalls of compounded glutathione products currently underway at pharmacies linked to this investigation. Sequester any potentially implicated product in your possession and follow return instructions from the compounding pharmacy.
• Identify and evaluate patients who develop signs or symptoms during or after receiving injectable glutathione, including fever, chills, myalgia, nausea, vomiting, hypotension, tachycardia, or injection-site reactions. Refer patients to the appropriate level of medical care as indicated.
• Report suspected adverse events to FDA MedWatch and to your state or local health department (see "Reporting adverse events" below).

For compounding pharmacies

• Do not use dietary supplement grade glutathione — or any dietary supplement grade ingredient — to compound sterile injectable drugs. Components used in injectable drugs must be appropriate for the intended route of administration.
• Know your suppliers. Confirm with ingredient suppliers, including repackagers, that ingredients used to compound injectable drugs are manufactured under conditions and specifications appropriate for the intended route of administration. Ensure a current, complete Certificate of Analysis (COA) is on file for the specific lot, including the name of the tests performed, acceptance criteria, results, and testing methodology. Tests that appear in a COA include identity, assay, purity, microbial limits and enumeration, and bacterial endotoxin.
• Do not rely on testing alone to ensure the quality of a compounded drug. Quality should be built into every step of the compounding process, including ingredient sourcing, stock solution preparation, and final preparation release, consistent with USP General Chapter <797> Pharmaceutical Compounding — Sterile Preparations.
• Review recent glutathione inventory and compounding records. If you received glutathione ingredient labeled as a dietary supplement or dietary supplement grade, discontinue its use in sterile injectable compounding and contact any customers who received affected product.
• Coordinate with your state Board of Pharmacy on any recalls or notifications and cooperate with FDA, CDC, and state/local health departments on public health investigation activities as requested.

For patients & consumers considering or receiving injectable glutathione

• Know what you are receiving. There is no FDA-approved glutathione drug product in the United States. Injectable glutathione is a compounded medication, typically prepared by a licensed compounding facility.
  

• If you recently received injectable glutathione and develop symptoms such as fever, chills, severe body aches, nausea, vomiting, dizziness, lightheadedness, or pain, swelling, or redness at the injection site, contact your healthcare provider promptly. Seek emergency care for severe symptoms (for example, difficulty breathing, fainting, or signs of shock).
• Report your experience to your healthcare provider and to FDA MedWatch (see below).

Reporting adverse events

Suspected adverse events: Report to FDA MedWatch. FDA encourages consumers, health care professionals, and compounders to report adverse events or quality problems with compounded drugs. You can report to FDA MedWatch in either of these ways:

Complete and submit a report online, or

Download and complete the form, then fax it to 1-800-FDA-0178.

Suspected outbreaks or clusters: Notify your state or local health department. State health departments can contact CDC's Division of Healthcare Quality Promotion for outbreak-response consultation.

Compounding quality concerns: Report to FDA and your state Board of Pharmacy.