FDA MedWatch - Compounded Glutathione by Greenwich Rx

If your email program has trouble displaying this email, view as a webpage.

TOPIC: Compounded Glutathione by Greenwich Rx: Recall - Due to Elevated Endotoxin Levels

AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy

ISSUE: Greenwich Rx is recalling specific lots of its compounded glutathione due to potential elevated endotoxin levels.

Risk Statement: There is 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. 

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Glutathione is a naturally occurring antioxidant that helps protect cells from oxidative stress and it is intended for subcutaneous injection.

RECOMMENDATIONS: 

• 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:

• Complete and submit the report online.

• Download the form or call 1-800-332-1088 to request a reporting form, then complete it and return it to the address on form or submit it by fax to 1-800-FDA-0178.

Follow us on X at @FDArecalls