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Greenwich Rx Recalls Compounded Glutathione Nationwide Over Elevated Endotoxin Levels

Map marker: Texas

Texas compounding pharmacy Greenwich Rx is voluntarily recalling specific lots of its compounded glutathione to the consumer level over potential elevated endotoxin levels, according to a company announcement posted by the FDA. The agency posts these notices as a public service and says it does not endorse either the product or the company.

Glutathione is a naturally occurring antioxidant that helps protect cells from oxidative stress, and it has become a fixture of the injectable wellness market. Greenwich Rx is a 503A compounding pharmacy, which means the product was made to order rather than manufactured under the approval pathway most consumers assume sits behind anything that comes in a vial.

What is affected

The recall covers compounded glutathione at 200 mg/mL, dispensed in 10 mL multidose vials and intended for subcutaneous injection. The product went to patients nationwide between June 26, 2026, and September 21, 2026.

Greenwich Rx says it is notifying customers by mail, and that anyone holding a recalled lot should stop using the product and follow the disposal instructions in the notification. Lot numbers and beyond use dates appear on the product label.

Why endotoxins matter

The company's risk statement is unusually blunt for a voluntary recall. It says there is a reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events including fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

Endotoxin contamination is a sterility and quality-control failure rather than an ingredient problem, which is precisely the category of risk that compounding has always carried and that marketing for injectable antioxidants almost never mentions.

Two emergency department reports

Greenwich Rx says it has received two reports involving patients who received emergency department care following intravenous administration of a glutathione product that was not formulated for IV use. The recalled product is labeled for subcutaneous injection, and the company does not link those two reports to the endotoxin issue.

That detail is worth sitting with. A product sold for one route being put into a vein is a separate failure mode from a contaminated lot, and both turned up around the same product line.

Bottom line

The recall is being conducted with the knowledge of the FDA, and the company says patients who think they have experienced a related health issue should contact their healthcare provider. Questions are being handled by Sedgwick at (866) 552-4916.

Source: FDA — MedWatch Safety Alerts. Read the original.

Filed under: fda, supply

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