A Houston-based compounding pharmacy is recalling six lots of injectable wellness products distributed nationwide after nine consumers reported reactions including fever, chills, nausea, vomiting, chest pain, headache and malaise. Centric Compounding pulled glutathione, Myer's Cocktail and Tri-Immune Boost vials over concerns that the glutathione active pharmaceutical ingredient used in the products contained elevated bacterial endotoxin levels.
The recall covers 30 mL multidose vials with expiration dates ranging from August 7 through September 25, 2026, according to the Houston Chronicle. The products were sold nationwide at the consumer level through both home delivery and healthcare providers, and were marketed for general wellness, immunity support and fatigue treatment. The FDA published the voluntary recall notice on September 13, noting that Centric Compounding initiated the action on September 9 after receiving the nine adverse event reports.
The affected products span three specific formulations. The recall includes Glutathione 200 mg/mL in lots 062326:B, 070826:A, and 072726:D; Myer's Cocktail, a blend of vitamins and minerals administered intravenously, in lots 070226:D and 072126:A; and Tri-Immune Boost, which contains vitamin C, glutathione and zinc sulfate for immune support, in lot 071626:B. Centric Compounding is notifying distributors and consumers by email and has arranged replacement products for those affected, while urging anyone with the recalled vials to stop using them and discard the product.
Why Endotoxins Slip Past Standard Sterilization
Glutathione itself is an antioxidant the body produces naturally, and it's marketed for immune support and skin lightening. The FDA's 2019 safety communication warned against using dietary-grade glutathione in sterile injectables after seven patients suffered pyrogenic reactions tied to endotoxin levels up to five times the safe limit. Bacterial endotoxins are toxic lipopolysaccharides shed from the outer wall of Gram-negative bacteria, and they can persist in a solution even after heat or filtration kills the living bacteria, according to Veolia Water Technologies. Once in the bloodstream, those endotoxins can trigger high fever, systemic inflammation, severe hypotension, organ failure and septic shock — consistent with the fever, hypotension and inflammatory reactions the FDA says elevated endotoxin levels can cause, up to and including potentially fatal anaphylactic shock and death.
That's why federal compounding standards exist specifically to catch what sterility testing alone misses. Under United States Pharmacopeia Chapter 797, Category 2 and Category 3 injectables made from nonsterile bulk ingredients are required to undergo bacterial endotoxin testing before release, per the Health Law Alliance. USP Chapter 797 calculates the endotoxin limit using K divided by M, with the limit depending on dose, route and body weight, as detailed by BA Sciences. That testing typically relies on Limulus Amebocyte Lysate, an extract from Atlantic horseshoe crab blood that reacts measurably when exposed to endotoxins, as described by LGM Pharma.
Part of a Wider Texas Compounding Problem
Centric Compounding's recall is not an isolated event. It follows two other Texas compounding pharmacies that issued nationwide recalls for 200 mg/mL glutathione injectables in August over elevated endotoxin levels — Victory Medical Center Pharmacy in Austin on August 5 and Optimal Balance Pharmacy in Houston on August 19, according to the MedShadow Foundation. Optimal Balance's recalled lot had already reached 14 states before patient reactions were logged, the same report notes.
The pattern traces back further still. At least 30 patients experienced adverse events after IV glutathione, including fever, chills, dizziness, sepsis-like symptoms and hospitalizations. The agency has flagged that dietary supplement-grade active pharmaceutical ingredients lack the purity and endotoxin controls required for sterile drug manufacturing.
An Unregulated Wellness Market Keeps Growing
The products swept into these recalls — glutathione, Myer's Cocktail or Tri-Immune Boost — are described as compounded wellness products, per MedShadow. Compounding pharmacies operate under Section 503A or 503B rules to prepare tailored medications outside the standard drug-approval pipeline, a distinction that has done little to slow demand. Compounding pharmacies are part of the market for boutique wellness injectables, even as supply-chain vulnerabilities persist.
