Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, is voluntarily recalling specific lots of its compounded glutathione to the consumer level due to potential elevated endotoxin levels, the US Food and Drug Administration said.
The recall was announced in an immediate release dated October 1, 2026.
According to a risk statement, 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 recall applies to specific lots of the compounded product and covers consumers nationwide.