Recall - Greewich (Glutathione Injection) produced by Greenwich Rx - Potential elevated endotoxin levels

Summary

Company Announcement

IMMEDIATE RELEASE - Tomball, Texas - October 1, 2026 - Greenwich Rx, a 503A compounding pharmacy, is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled 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.

Glutathione is a naturally occurring antioxidant that helps protect cells from oxidative stress. The voluntary recall affects the following lots of compounded glutathione 200 mg/mL dispensed in 10mL multidose vials and intended for subcutaneous injection:

The glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026. Refer to the photo of the product label below for the location of lot number and beyond use date.

Greenwich Rx is notifying customers of this voluntary recall by mail. 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 [email protected] Monday through Friday between 8:00 AM to 5:00 PM Eastern Time.

Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.