Ten lots of an injected antioxidant were recalled over endotoxin levels

Lot 0060-062426-1 is the oldest of ten lots of glutathione injection that Greenwich Rx, a compounding pharmacy in Tomball, Texas, has recalled nationwide because the vials hold elevated levels of endotoxin. Its labeled expiration date was October 2, which has now passed. The newest, 0060-080426-1, runs to November 12, so a number of the recalled vials are still within date.

Glutathione is an antioxidant the body makes on its own, and compounding pharmacies prepare it as a shot for patients whose prescribers want it delivered by injection.

Ten Lots, 200 mg/mL, Ten-Milliliter Vials

On October 1 the FDA posted Greenwich Rx’s recall notice, which covers glutathione injection at 200 mg/mL in 10 mL multidose vials intended for subcutaneous use. The ten lots and their expiration dates are 0060-062426-1 (10/02/2026), 0060-062726-1 (10/05/2026), 0060-070926-1 (10/17/2026), 0060-071426-1 and 0060-071426-2 (both 10/22/2026), 0060-072026-1 (10/28/2026), 0060-072726-1 (11/04/2026), 0060-072926-1 (11/06/2026), 0060-073126-1 (11/08/2026) and 0060-080426-1 (11/12/2026).

The product shipped nationwide between June 26 and September 21, 2026, a span of a little under twelve weeks. Nothing in the notice describes how many vials that represents, which pharmacies or clinics received them, or how many patients were dispensed product from the ten lots, and the oldest lot has already aged out of its labeled shelf life while the second reaches its expiration date on October 5.

Endotoxin, Injected

Endotoxins are fragments of bacterial cell walls, and they matter in injectable drugs because they can persist in a vial even when the bacteria that shed them are gone. Sterilizing the liquid does not necessarily remove them, and the body reacts to them strongly when they are delivered straight into tissue or the bloodstream, where the immune response can run well beyond the injection site. The notice states the danger in one sentence: “Injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death.”

The notice also reports two adverse events. Two patients received emergency department care after intravenous administration of the glutathione, even though the vials are labeled for subcutaneous injection. Greenwich Rx does not say in the notice how the endotoxin was detected, and it gives no measured level, so the word “elevated” is the only quantitative description on offer. The recall is described as voluntary.

FDA runs a reporting channel for exactly this kind of event. Its MedWatch program accepts reports from health professionals, patients and consumers about serious problems with medical products, and the agency issues public alerts when the reports warrant them. Reports of this kind are how a pattern becomes visible: one hospital visit after one vial is an anecdote, while the same signal arriving from several states is what turns into a recall.

Two Earlier Glutathione Recalls Since August

The Greenwich notice follows two earlier compounded glutathione recalls over the same contaminant. On August 10, Victory Medical Center Pharmacy of Austin recalled three lots of glutathione vials over elevated endotoxin, according to a summary on SafeMedicines.org that lists reactions including nausea, vomiting, tachycardia and injection site reactions and quotes the FDA’s warning that anaphylactic shock and death are associated with high endotoxin levels in injectable products. On August 19, Optimal Balance Pharmacy of Houston recalled one lot, LG342009076, after pharmacy testing identified elevated bacterial endotoxin, according to its FDA-posted notice, which lists symptoms among reported events including fever, chills, severe headache, nausea and vomiting.

In between the two recalls, FDA issued a warning to compounders. As reported by PharmaNow, the August 27 alert said that dietary-supplement-grade ingredients carry no assurance of the purity, endotoxin control or sterility required for injectables, and it described a Medisca lot tied to harmful reactions in 30 patients.

Greenwich Rx is a 503A pharmacy, and that status shapes what regulators check. Section 503A of the Federal Food, Drug, and Cosmetic Act exempts compounded drugs made against patient-specific prescriptions from FDA approval and from current good manufacturing practice rules. In its compounding guidance, the agency states plainly that compounded drugs are not FDA-approved and that FDA does not review them for safety, effectiveness or quality before they reach patients. The same page contrasts 503A pharmacies with 503B outsourcing facilities, which must follow current good manufacturing practice and face FDA inspection, and it cites a 2012 Massachusetts pharmacy contamination episode that produced more than 750 infections and more than 60 deaths in 20 states.

That leaves the Greenwich lots with a question the notice does not settle: whether the ingredient, the compounding or the filling introduced the endotoxin, a distinction that matters because the August warning pointed to ingredient grade as one weak point.

This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.

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