An anti-aging and wellness supplement is being recalled amid fears it may be contaminated with toxins.
The FDA one announced to remind of Optimal Balance Pharmacy’s compounded glutathione 200 mg/ml (30 ml) multidose vial as testing by the pharmacy revealed elevated bacterial endotoxin levels.
An endotoxin is a poisonous molecule found in bacteria such as E.coli and Salmonella. It can cause severe fever, inflammation and… sepsis.
The FDA stated: ‘There is a reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events, including fever, hypotension, inflammatory reactions, anaphylactic shock and death.’
As of August 19, Optimal Balance Pharmacy has received reports of side effects from people using the product.
Neither the company nor the FDA has disclosed how many incidents have been reported, but they include fever, chills, severe headache, nausea, vomiting, pain and symptoms consistent with an allergic reaction.
The injectable 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 commonly used to help fight cell damagesupport the immune system and pure toxins from the liver.
The FDA announced that Optimal Balance Pharmacy is recalling its compounded glutathione 200 mg/ml (30 ml) multidose vials after the pharmacy’s own testing revealed elevated bacterial endotoxin levels
Optimal Balance Pharmacy is notifying customers and working to collect and properly dispose of the recalled products.
The company is a compounding pharmacy, meaning it prepares custom medications by combining ingredients to meet individual patient needs.
Unlike FDA-approved medications, compounded medications are not reviewed for safety, effectiveness, or quality before they reach the patient.
People who currently have a recalled injectable drug 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 crucial 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 medical spas for a range of off-label uses, including skin lightening, anti-aging, detoxification, and immune system support.
Because oral glutathione is poorly absorbed, injections are promoted as a more effective way to achieve therapeutic levels.
The injectable was shipped to prescribers and directly to consumers in 14 states. Glutathione injections are commonly used to combat cell damage, support the immune system, and remove toxins from the liver
However, the FDA has not reviewed or approved any injectable glutathione product for safety or effectiveness for these purposes.
The scientific basis for these uses remains thin, and medical organizations have warned against off-label use due to 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 such as E. coli. It’s not the bacteria themselves, which means 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. Ingesting endotoxins is generally harmless, but injecting them into the bloodstream causes an immediate and aggressive immune response. Responses can begin within minutes.
The FDA warns that injectable products with elevated endotoxin levels can cause fever, hypotension, inflammatory reactions, anaphylactic shock and death.
Symptoms typically appear within minutes to hours and include fever, chills, severe headache, nausea, vomiting, body aches, and a rapid heart rate.
Seek emergency care for difficulty breathing, swelling of the throat or face, chest pain, fainting, confusion, a fast-spreading rash, or a sudden fever above 102 degrees F.
As of August 19, Optimal Balance Pharmacy has received reports of adverse reactions from people who have used the product, but has not disclosed how many incidents have been reported. Reactions include fever, severe headache, nausea, pain and allergic symptoms
The Optimal Balance Pharmacy recall comes just two weeks after a separate pharmacy in Texas 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 defect. Two separate pharmacies failing the same measure for the same product within weeks indicates a potential problem further down the supply chain.
This pattern has raised regulatory questions. Glutathione is not listed by the FDA as an approved compounding ingredient and is regulated as a dietary supplement rather than a pharmaceutical drug.
The consequences of the first recall have already begun. A Texas woman has filed a lawsuit against the pharmacy, claiming she was hospitalized after receiving an IV infusion from one of the recalled lots.
The lawsuit alleges that within minutes of the infusion, she experienced head and neck pressure, uncontrollable shaking, and increased heart rate and blood pressure, requiring ambulance transport and a multi-day hospital stay.
The lawsuit has not been heard in court and the pharmacy has not responded publicly.
