Centric Compounding, a Texas-based pharmacy, is voluntarily recalling six lots of Glutathione, Myers' Cocktail and Tri-Immune Boost injectable vials after testing found the products were compounded with a glutathione active pharmaceutical ingredient containing elevated endotoxin levels.
The products were distributed nationwide to patients through home delivery and to prescribers, according to the U.S. Food and Drug Administration.
The FDA said in its recall statement that "there is reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death."
Endotoxins are toxic molecules that can trigger sepsis, a severe and sometimes fatal immune response in which the body attacks its own organs.
So far, the agency said, Centric Compounding has received nine reports of fever, chills, chest pain, nausea, vomiting, headache and malaise, a generalized feeling of illness that includes fatigue and body aches.
Which lots are affected
The recall covers:
- Glutathione 200mg/ml 30mL vials with expiration dates of August 7, August 22 and September 25, 2026
- Myers' Cocktail 30mL vials with expiration dates of August 16 and September 4, 2026
- Tri-Immune Boost 30mL vials with an expiration date of August 30, 2026
Why glutathione is injected
The FDA notes the products are used to support immunity, fatigue and general wellness. Glutathione is produced naturally in the body and acts as an antioxidant. Injections are often used to help fight cell damage, support the immune system and clear toxins from the liver.
Injectable glutathione is commonly marketed at wellness clinics and medical spas for off-label uses including skin lightening, anti-aging, detoxification and immune support. Because oral glutathione is poorly absorbed by the body, injections are promoted as a more effective way to reach therapeutic levels.
The FDA has not reviewed or approved any injectable glutathione product for safety or effectiveness for these purposes. Medical organizations have cautioned against such off-label use because of limited clinical evidence and significant health risks.
Myers' Cocktail is a blend of vitamins and minerals given intravenously, though experts say many of its claimed benefits are limited. Tri-Immune Boost contains vitamin C, glutathione and zinc sulfate, and is marketed for immune support.
How endotoxins cause harm
Endotoxins are toxic molecules found in bacteria such as E. coli and Salmonella. They are not the bacteria themselves, meaning a product can pass a sterility test and still be dangerous. Heat does not destroy them.
The danger depends on how the product enters the body. Swallowing endotoxins is generally harmless, but injecting them into the bloodstream triggers an immediate and aggressive immune response, with reactions that can begin within minutes.
Symptoms to watch for
The FDA said symptoms typically appear within minutes to hours and include fever, shaking chills, severe headache, nausea, vomiting, body aches and a rapid heartbeat.
The agency advised anyone experiencing difficulty breathing, throat or facial swelling, chest pain, fainting, confusion, a rapidly spreading rash, or a sudden fever above 102 degrees Fahrenheit to seek emergency care immediately.
What happens next
Centric Compounding is notifying its distributors and customers of the recall by email and is arranging replacement of all recalled products, the FDA said.
Anyone who has the affected products should immediately stop using them and throw them away, according to the FDA.
