Greenwich Rx recalls compounded glutathione nationwide due to elevated endotoxin levels

Greenwich Rx, a compounding pharmacy in Tomball, Texas, voluntarily recalls specific lots of its compounded glutathione 200 mg/mL nationwide due to potential elevated endotoxin levels. The product, distributed between June 26, 2026, and September 21, 2026, is intended for subcutaneous injection. However, Greenwich Rx has received two reports of patients requiring emergency department care after receiving the drug intravenously. Elevated endotoxins in injectables can cause fevers, low blood pressure, and death.

Scope and cause of the recall

• ▪The recalled Greenwich Rx compounded glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026.
• ▪Greenwich Rx initiated the voluntary recall of its compounded glutathione due to potential elevated endotoxin levels in the product.
• ▪Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, voluntarily recalled specific lots of its compounded glutathione 200 mg/mL dispensed in 10mL multidose vials.

Reports of incorrect administration

• ▪Greenwich Rx received two reports of patients who required emergency department care after receiving intravenous administration of a glutathione product not formulated for intravenous use.
• ▪The recalled Greenwich Rx glutathione product was intended for subcutaneous injection, but Greenwich Rx received reports of patients receiving it via intravenous administration.

Information for affected customers

• ▪Customers can direct questions regarding the Greenwich Rx recall to Sedgwick at (866) 552-4916 or via email at GreenwichRx7542@sedgwick.com.
• ▪Greenwich Rx is notifying customers of the voluntary recall by mail, instructing them to stop using the product and follow provided disposal instructions.

Reporting health issues

• ▪Patients who experience health issues related to the recalled Greenwich Rx glutathione are advised to contact their healthcare provider.
• ▪Patients can report adverse reactions or quality problems experienced with the Greenwich Rx glutathione to the FDA's MedWatch Adverse Event Reporting program.

Debatable claims

• ▪Healthcare providers bear primary responsibility for the Greenwich Rx adverse events
• ▪Compounded glutathione injections do more harm than good
• ▪The FDA should tighten regulations on 503A compounding pharmacies