Optimal Balance Pharmacy is voluntarily recalling its compounded glutathione 200 mg/mL (30 mL) multi-dose vials after internal testing revealed elevated levels of bacterial endotoxins, the U.S. Food and Drug Administration (FDA) announced.
Bacterial endotoxins are toxic molecules found in certain bacteria, such as E. coli and Salmonella. These toxins can trigger severe fevers, inflammation, and sepsis in individuals who receive an injection. The FDA stated that injectable products with elevated endotoxin levels carry a "reasonable probability of death" and can cause "significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death."
As of August 19, Optimal Balance Pharmacy reported receiving adverse event reports from users of the recalled product. While the exact number of incidents was not disclosed, reported symptoms include fever, chills, severe headache, nausea, vomiting, pain, and reactions consistent with an allergic response.
The recalled injectable was distributed to prescribers and directly to consumers in 14 states: Arizona, Colorado, Florida, Illinois, Louisiana, Michigan, New York, Nevada, Oklahoma, Pennsylvania, Texas, Utah, Vermont, and Washington.
Optimal Balance Pharmacy is a compounding pharmacy, which prepares customized medications by combining ingredients. Unlike FDA-approved drugs, compounded medications do not undergo pre-market review by the FDA for safety, effectiveness, or quality.
Glutathione, a naturally occurring antioxidant composed of cysteine, glycine, and glutamic acid, is often used in wellness settings for its purported benefits in fighting cell damage, supporting the immune system, and aiding liver detoxification. Injectable forms are promoted for anti-aging and skin lightening, with proponents suggesting injections are more effective than oral supplements due to poor absorption.
However, the FDA has not approved any injectable glutathione product for these uses, and clinical evidence supporting these off-label applications remains limited. Medical organizations have cautioned against such uses due to insufficient clinical data and potential health risks. The FDA has also noted that endotoxins are not destroyed by heat and can cause severe immune responses when injected directly into the bloodstream, with reactions potentially occurring within minutes.
Symptoms of endotoxin exposure from injections can manifest rapidly and include fever, shaking chills, severe headache, nausea, vomiting, body aches, and rapid heartbeat. The FDA advises individuals experiencing difficulty breathing, facial or throat swelling, chest pain, fainting, confusion, a rapidly spreading rash, or a fever above 102 degrees Fahrenheit after using the product to seek emergency medical care.
The recall of Optimal Balance Pharmacy's product follows a similar recall just two weeks prior by a Texas pharmacy that withdrew three lots of the same injectable glutathione for the identical reason: elevated bacterial endotoxin levels. This pattern raises concerns about potential issues within the broader supply chain for such compounded products.
Following the initial recall, a lawsuit was filed against the Texas pharmacy by a woman who alleged hospitalization after receiving an infusion from a recalled lot, experiencing symptoms including head and neck pressure, uncontrollable shaking, and elevated vital signs. This lawsuit has not yet been adjudicated, and the pharmacy has not publicly responded.