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Health & beauty United States Recall

Greenwich Rx Issues Voluntary Nationwide Recall of Compounded Glutathione Due to Elevated Endotoxin Levels

Glutathione Injection
Image: U.S. Food and Drug Administration

What's being recalled

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:

Product: Glutathione Injection; Strength: 200 mg/mL; Package Size: 10mL; Lot Number: 0060-062426-1; Beyond Use Date: 10/02/2026

Product: 0060-062726-1; Strength: 10/05/2026

Product: 0060-070926-1; Strength: 10/17/2026

Product: 0060-071426-1; Strength: 10/22/2026

Product: 0060-071426-2; Strength: 10/22/2026

Product: 0060-072026-1; Strength: 10/28/2026

Product: 0060-072726-1; Strength: 11/04/2026

Product: 0060-072926-1; Strength: 11/06/2026

Product: 0060-073126-1; Strength: 11/08/2026

Product: 0060-080426-1; Strength: 11/12/2026

Customers can direct questions regarding this recall to Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com 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.

Company Contact Information

Consumers:

Sedgwick

(866) 552-4916

GreenwichRx7542@sedgwick.com

Media:

Lauren Jennings and Don Williams, Glodow Nead Communications

GreenwichRxPR@glodownead.com

Product Photos

The hazard

Potential elevated endotoxin levels

What to do

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.

Contact: Consumers: Sedgwick (866) 552-4916 GreenwichRx7542@sedgwick.com Media: Lauren Jennings and Don Williams, Glodow Nead Communications GreenwichRxPR@glodownead.com

Where it was sold

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.

The official notice

This page is a summary of the notice published by U.S. Food and Drug Administration, collected from U.S. Food and Drug Administration. Check the original before you act on it.

Read the official notice (opens in a new tab)

A little guidance

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