Endotoxin Risk Prompts Recall of Greenwich Rx Compounded Glutathione 2026

Injectable products contaminated with elevated endotoxin levels can trigger fevers, dangerously low blood pressure, severe inflammatory reactions, anaphylactic shock and even death. That is the risk behind a voluntary nationwide recall of compounded glutathione injection issued by Greenwich Rx, a 503A compounding pharmacy based in Tomball, Texas, on October 1, 2026.

If you or someone you care for was dispensed glutathione by Greenwich Rx this summer, it is worth checking your vial today. The recall reaches all the way to the consumer level, which means patients who hold the product at home are being asked to act.

Recalled Products at a Glance

The recall covers compounded glutathione 200 mg/mL, dispensed in 10 mL multidose vials and intended for subcutaneous injection. Ten specific lots are involved. Each lot number and its beyond use date is listed below.

• 0060-062426-1 – beyond use date 10/02/2026
• 0060-062726-1 – beyond use date 10/05/2026
• 0060-070926-1 – beyond use date 10/17/2026
• 0060-071426-1 – beyond use date 10/22/2026
• 0060-071426-2 – beyond use date 10/22/2026
• 0060-072026-1 – beyond use date 10/28/2026
• 0060-072726-1 – beyond use date 11/04/2026
• 0060-072926-1 – beyond use date 11/06/2026
• 0060-073126-1 – beyond use date 11/08/2026
• 0060-080426-1 – beyond use date 11/12/2026

The lot number and beyond use date appear on the product label. The company’s announcement includes a photo of the label showing where to find them.

What Triggered the Recall

Greenwich Rx is recalling the product because of potential elevated endotoxin levels. Endotoxins are toxic substances associated with certain bacteria, and they are a particular concern in anything injected into the body.

The company said it has received two reports involving patients who needed emergency department care after receiving intravenous (IV) administration of a glutathione product. That product was not formulated for IV use. The announcement does not state that those patients were confirmed to have received product from the recalled lots.

In its risk statement, the company said there is a reasonable probability that injectable products with elevated endotoxin levels could cause significant medical events. These include fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

Who Is Affected?

The glutathione was distributed to patients nationwide between June 26, 2026, and September 21, 2026. Because the recall is at the consumer level, anyone who received a vial from one of the lots above is affected, regardless of where in the United States they live.

Several of the beyond use dates fall in the coming days and weeks, so some patients may still have unused vials on hand. Anyone unsure which lot they received should check the label or contact the company.

Steps Consumers Should Take

Greenwich Rx is notifying customers of the recall by mail. Here is what the company asks patients to do:

• Check your vial label for the lot number and beyond use date.
• If your vial matches one of the recalled lots, stop using it.
• Follow the disposal instructions provided in the recall notification you receive from Greenwich Rx.
• If you believe you have had a health problem that may be related to the product, contact your healthcare provider.

Questions about the recall can go to Sedgwick, the company’s recall contact, at (866) 552-4916 or by email at GreenwichRx7542@sedgwick.com. Lines are staffed Monday through Friday, 8:00 AM to 5:00 PM Eastern Time.

Patients and healthcare providers can also report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program. Reports can be filed online at www.fda.gov/medwatch/report.htm. They can also be sent by regular mail or fax: download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request one. The fax number is 1-800-FDA-0178.

From the Agency

The FDA posted the announcement as a public service, as it does for company-issued recalls, and noted that it does not endorse either the product or the company. The recall notice states that the action is being conducted with the knowledge of the FDA.

Media inquiries are handled by Lauren Jennings and Don Williams of Glodow Nead Communications.

Patients who use compounded injectable products should keep the original packaging and label information, since lot numbers are the fastest way to determine whether a product is part of a recall. Anyone with concerns about a prescribed injection should talk with their prescriber or pharmacist.