Fourth Texas pharmacy recalls IV glutathione as FDA endotoxin warnings widen

A Texas compounding pharmacy has pulled all remaining lots of its injectable glutathione from the market after two patients required emergency treatment, becoming the fourth U.S. pharmacy since August to recall the popular "wellness shot" over contamination with bacterial toxins.

Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, announced a voluntary nationwide recall on Wednesday of its compounded Glutathione Injection, 200 mg/mL, citing the potential for elevated endotoxin levels. The product, sold in 10-mL multidose vials and labeled for subcutaneous use, had been shipped nationwide between June 26 and September 21, reaching medical spas, wellness clinics and telehealth prescribers rather than traditional retail pharmacies.

The numbers

The recall covers ten specific lots with "beyond-use" dates ranging from October 2 through November 12, 2026. According to the company's notice posted through the FDA's recalls database, Greenwich Rx has so far received two reports of patients who needed emergency department care after receiving the glutathione intravenously, even though the product was formulated only for injection under the skin. The company's notice warns that elevated endotoxin levels in an injectable drug carry a "reasonable probability" of causing fevers, dangerously low blood pressure, inflammatory reactions, anaphylactic shock and death.

The Greenwich Rx cases sit inside a larger, still-growing tally. The CDC's running case count for the broader glutathione-endotoxin investigation stood at more than 25 illnesses across at least four states — Texas, Washington, Florida and New York — as of its most recent update, with at least three patients hospitalized, including one who required intensive care. Separately, the FDA has said it is aware of at least 30 adverse-event reports tied to the underlying contaminated ingredient supply. Greenwich Rx is directing patients, clinics and wellness providers who hold any of the affected lots to stop using the product immediately and follow the company's disposal instructions, with questions routed to the claims administrator Sedgwick at (866) 552-4916.

How we got here

The Greenwich Rx action traces back to a common ingredient problem that has now touched a handful of pharmacies. In an August notice, the FDA said it was tracking adverse events tied to intravenous glutathione compounded from raw material supplied by Medisca Inc. that was labeled for dietary-supplement use rather than for sterile injectable drugs. The agency said supplement-grade ingredients are not manufactured or tested to the standards required for anything injected into the bloodstream, leaving them vulnerable to bacterial endotoxins that can survive even after a finished product is sterilized and tests sterile for live organisms.

Since early August, three other pharmacies — Victory Medical Center Pharmacy, Optimal Balance Pharmacy and Centric Compounding — have issued similar recalls of glutathione and related "wellness cocktail" injectables, including Myers' Cocktail and Tri-Immune Boost vials, after their own testing or adverse-event reports turned up elevated endotoxin levels, as previously reported. Medisca told the FDA in August that it had warned its customers not to use the dietary-supplement-grade material in sterile compounding, and the agency has urged any compounder that received the ingredient to contact patients and halt use immediately.

The episode has unfolded against a broader boom in intravenous "glow-up" treatments — glutathione drips, vitamin cocktails and compounded weight-loss injections sold through medical spas, telehealth platforms and home-delivery IV services that operate under the looser manufacturing rules that apply to small-batch pharmacy compounding rather than the rigorous testing required of FDA-approved, mass-manufactured drugs. Compounding is legal and often medically necessary, typically used to create custom doses or formulations unavailable commercially, but it has repeatedly been the source of serious contamination outbreaks when sterile technique or ingredient sourcing breaks down.

Who is affected

Because Greenwich Rx distributed the recalled lots nationwide to clinics, medical spas and telehealth prescribers rather than directly to consumers, the FDA, CDC and the company are relying heavily on provider notifications to reach patients who may have already received the injections. People who received a glutathione shot from a provider sourcing from Greenwich Rx between late June and late September are being urged to check their lot number against the recalled list and watch for fever, chills, rapid heartbeat, severe headache or signs of an allergic reaction in the days after an injection.

Compounded injectables like these are not confined to niche wellness clinics; similar glutathione and vitamin infusions are widely marketed for immune support, skin brightening, athletic recovery and hangover relief, meaning the pool of potentially exposed consumers extends well beyond people who think of themselves as patients at all. The CDC's guidance specifically asks patients considering any IV glutathione treatment to ask their provider where the drug was compounded and whether the ingredient supplier has been linked to the ongoing investigation.

Reaction

Physicians have been warning for weeks that the risk from endotoxin-contaminated injectables is especially serious because it bypasses the body's normal defenses against contamination in a way that an oral or topical product would not. Commenting on an earlier recall in the same cluster, physician Dr. Beverley Kraszewski explained why the intravenous route makes the danger acute.

"When an [endotoxin] enters the body intravenously, it can circulate rapidly and activate immune cells creating a severe systemic immune response," Kraszewski said.

Patient-safety advocates have also pointed to the pattern of repeat recalls as evidence that oversight of the compounding ingredient supply chain has not kept pace with consumer demand for IV wellness treatments, many of which are marketed directly to consumers through social media and telehealth apps with little clinical evidence behind their purported anti-aging or detox benefits.

What happens next

Neither the FDA nor CDC has announced a formal, agency-ordered recall or a blanket market withdrawal of glutathione injectables, leaving much of the response in the hands of individual compounding pharmacies as they discover problems with their own supply chains. Both agencies say their joint investigation into the Medisca-linked contamination remains open, and they are encouraging healthcare providers and patients to report any reactions through the FDA's MedWatch adverse-event system. Greenwich Rx said it is working with regulators as it completes the recall, and patients or providers with unused vials from the affected lots are advised to contact the company's claims line for return or disposal instructions rather than discarding them in household trash. Given the recurring pattern of recalls over the past two months, consumer-safety advocates say additional pharmacies that received the implicated glutathione lot could still come forward in the weeks ahead.