A nationwide recall has been issued for several compounded intravenous wellness products after testing found elevated endotoxin levels in an ingredient used to make the injections, raising the risk of serious and potentially fatal reactions, according to the U.S. Food and Drug Administration (FDA). The FDA said the recall, which was made on September 9, covers six lots of Glutathione, Myer's Cocktail, and Tri-Immune Boost injectable vials from Centric Compounding LLC, which were distributed nationwide directly to patients through home delivery services and to healthcare prescribers.
The agency reported that the products were compounded using a glutathione active pharmaceutical ingredient contaminated with elevated levels of endotoxins—bacterial toxins that can trigger severe immune responses when introduced directly into the bloodstream. Newsweek reached out to Centric Compounding by email Sunday for comment. "Endotoxin in IV solution are unlike bacteria.
They are components of the outer membranes of some bacteria like gram-negative bacteria," Dr. Beverley Kraszewski, medical director of IV Evolution Medical, a medical spa in Syosset, New York, told Newsweek in a statement Sunday. She added: "When an [endotoxin] enters the body intravenously, it can circulate rapidly and activate immune cells creating a severe systemic immune response.
Intravenous exposure is very concerning because of bypasses [the body's] normal barriers to prevent infection." The three recalled formulations are commonly marketed by IV clinics, telehealth providers, and home delivery services to support immunity, combat fatigue, and promote general wellness: Centric Compounding reported receiving nine adverse event reports linked to the products, with symptoms including fever, chills, chest pain, nausea, vomiting, headache, and malaise. Because intravenous administration allows contaminants to bypass natural bodily defenses, the FDA warned that exposure can lead to serious medical events, including low blood pressure, inflammatory reactions, anaphylactic shock, sepsis-like symptoms, and death. The action follows a recent FDA warning advising compounders against using dietary supplement-grade glutathione in injectable products after reports of severe adverse reactions requiring hospitalization.
Centric Compounding said it is notifying customers and distributors by email to arrange replacements. The FDA urges patients in possession of the affected vials to stop using them immediately and discard them, and to contact a healthcare provider if they experience adverse symptoms. Consumers can also report adverse reactions to the FDA's MedWatch reporting program.
"If you have gone to [an] IV or drip bar and have received a Myer's cocktail or glutathione mixture and have redness at the site of insertion, fever, chills, muscle aches, fatigue, or nausea proceed to your nearest emergency room," Kraszewski said. "You will need to get bloodwork, including blood cultures. If you are asymptomatic, I would still recommend getting bloodwork." Centric Compounding's recall comes amid heightened scrutiny of intravenous products following another recent nationwide recall involving a commonly used saline solution.
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