Greenwich Rx is recalling specific lots of its compounded glutathione due to potential elevated endotoxin levels, the US Food and Drug Administration said.
The FDA said 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.
To date, Greenwich Rx has received two reports involving patients who received emergency department care following intravenous (IV) administration of a glutathione product that was not formulated for IV use. The glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026.
Glutathione is a naturally occurring antioxidant that helps protect cells from oxidative stress and is intended for subcutaneous injection.
Customers who received glutathione from one of the recalled lots should stop using the product and follow the disposal instructions provided in the recall notification. Patients who believe they have experienced a health issue that may be related to the product should contact their healthcare provider.
Customers can direct questions regarding this recall to Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com.
Health care professionals, consumers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.