An anti-aging and wellness supplement is being recalled over fears it may be contaminated with toxins.
The FDA announced a recall of Optimal Balance Pharmacy’s compounded glutathione 200 mg/ml (30 ml) multi-dose vial because testing by the pharmacy revealed elevated bacterial endotoxin levels.
An endotoxin is a toxic molecule found in bacteria such as E.coli and Salmonella. It can cause severe fevers, inflammation and sepsis.
The FDA stated: ‘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.’
As of August 19, Optimal Balance Pharmacy has received reports of adverse events from people using the product.
Neither the company nor the FDA released how many incidents have been reported, but they include fever, chills, severe headache, nausea, vomiting, pain and symptoms consistent with an allergic reaction.
The injectible was shipped to prescribers and directly to consumers in Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont and Washington.
Glutathione injections are often used to help fight cell damage, support the immune system and clear toxins from the liver.
The FDA announced that Optimal Balance Pharmacy is recalling its compounded glutathione 200 mg/mL (30 mL) multi-dose vials after the pharmacy’s own testing detected elevated bacterial endotoxin levels
Optimal Balance Pharmacy is notifying customers and working to retrieve and properly dispose of the recalled products.
The company is a compounding pharmacy, meaning it prepares customized medications by combining ingredients to meet individual patient needs.
Unlike FDA-approved drugs, compounded medications are not reviewed for safety, effectiveness, or quality before they reach patients.
For people who currently have a recalled injectible, they should immediately stop using it and contact their prescriber or the company.
Glutathione is a powerful antioxidant that occurs naturally in every cell of the human body. It is composed of three amino acids – cysteine, glycine, and glutamic acid – and plays a vital role in protecting cells from damage caused by free radicals and oxidative stress.
In addition to its antioxidant properties, glutathione supports the immune system, helps the liver remove heavy metals and other toxins and is involved in DNA production and tissue repair.
Injectable glutathione is often marketed in wellness clinics and med spas for a range of off-label uses, including skin lightening, anti-aging, detoxification, and immune support.
Because oral glutathione is poorly absorbed, injections are promoted as a more effective way to reach therapeutic levels.
The injectible was shipped to prescribers and directly to consumers in 14 states. Glutathione injections are often used to help fight cell damage , support the immune system and clear toxins from the liver
However, the FDA has not reviewed or approved any injectable glutathione product for safety or effectiveness for these purposes.
The evidence base for these uses remains thin, and medical organizations have cautioned against off-label use because of limited clinical evidence and significant health risks.
Limited oversight of compounded injectables makes them vulnerable to contamination.
Endotoxins are toxic molecules found in the outer membrane of bacteria like E. coli. They are not the bacteria themselves, meaning a product can pass a sterility test and still be dangerous. Heat does not destroy them.
The risk 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. Reactions can begin within minutes.
The FDA warns that injectable products with elevated endotoxin levels can cause fevers, hypotension, inflammatory reactions, anaphylactic shock, and death.
Symptoms typically appear within minutes to hours and include fever, shaking chills, severe headache, nausea, vomiting, body aches and rapid heartbeat.
Seek emergency care for difficulty breathing, throat or facial swelling, chest pain, fainting, confusion, a rapidly spreading rash, or a sudden fever above 102 degrees F.
As of August 19, Optimal Balance Pharmacy has received reports of adverse events from people who used the product but has not disclosed how many incidents have been reported. The reactions include fever, severe headache, nausea, pain and allergic-type symptoms
The Optimal Balance Pharmacy recall comes just two weeks after a separate Texas pharmacy recalled three lots of the same injectable glutathione product for the exact same reason – elevated bacterial endotoxin levels.
A single isolated recall can be seen as a manufacturing slip. Two separate pharmacies failing on the same measure for the same product within weeks points to a potential problem further up the supply chain.
This pattern has raised regulatory questions. Glutathione is not listed as an approved ingredient for compounding by the FDA and is regulated as a dietary supplement rather than a pharmaceutical drug.
The fallout from the first recall has already begun. A Texas woman has filed a lawsuit against the pharmacy, alleging she was hospitalized after receiving an IV infusion from one of the recalled lots.
The lawsuit claims she experienced head and neck pressure, uncontrollable shaking, and elevated heart rate and blood pressure within minutes of the infusion, requiring ambulance transport and a multi-day hospital stay.
The lawsuit has not been heard in court and the pharmacy has not publicly responded.
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