Greenwich Rx, a 503A compounding pharmacy in Tomball, Texas, is recalling ten lots of compounded glutathione injection nationwide because of potentially elevated endotoxin levels. The company says it has received two reports of patients who needed emergency department care after a glutathione product was given intravenously, although the product was not formulated for IV use. It is the second recall of compounded glutathione over endotoxin in a month, after Centric Compounding in Houston.
What is being recalled
The recall, announced by the company and published by the FDA on 1 October, covers glutathione 200 mg/mL in 10 mL multidose vials intended for subcutaneous injection, with beyond-use dates from 2 October to 12 November 2026. The vials were distributed to patients nationwide between 26 June and 21 September, and the company is notifying customers by mail. Its announcement tells customers with recalled lots to stop using the product, and anyone who believes they have had a related health problem to contact a healthcare provider. The risk statement in the notice says injectable products with elevated endotoxin could cause fevers, low blood pressure, inflammatory reactions, anaphylactic shock and death.
Two details set this notice apart. The emergency visits followed intravenous use of a product the pharmacy says was made for injection under the skin, so the announcement itself describes it being given by a route it was not formulated for. And Greenwich Rx does not say where the endotoxin came from, whereas Centric traced its recall to a glutathione ingredient it had bought, after nine people reported reactions.
Why a second recall matters
Endotoxin is a fragment of the outer wall of certain bacteria. It survives the sterilisation that kills the bacteria themselves, so a vial can pass a sterility test and still provoke a serious inflammatory reaction when injected. Compounded drugs are not FDA-approved and are not reviewed by the agency for safety or effectiveness before they are dispensed. Two recalls of the same compounded ingredient for the same defect within a month is a pattern, and it applies to the channel as much as the ingredient: the same pharmacies and clinics also supply compounded GLP-1 drugs.
What is not yet known. The announcement does not say what caused the elevated endotoxin, whether it shares a raw-ingredient source with Centric’s, whether the two emergency patients received recalled lots, or who gave the product intravenously. Neither notice is an FDA enforcement action: both are voluntary recalls conducted with the agency’s knowledge. This article is shorter than our usual length because the announcement contains little more than is reported here.
Sources: Greenwich Rx issues voluntary nationwide recall of compounded glutathione due to elevated endotoxin levels, company announcement published by the FDA, 1 October 2026.
