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Greenwich Rx announced a voluntary nationwide recall of 10 lots of compounded glutathione injection because of potential elevated endotoxin levels. The company says it has received two reports of patients receiving emergency department care after IV use of a glutathione product that was not formulated for IV administration.
Greenwich Rx is voluntarily recalling 10 lots of its compounded glutathione injection across the United States because the products may have elevated endotoxin levels, according to a company announcement posted by the U.S. Food and Drug Administration on October 1, 2026. The recall covers 200 mg/mL glutathione in 10 mL multidose vials labeled for subcutaneous injection; the company says two patients required emergency department care after receiving a glutathione product intravenously that was not formulated for IV use.
The affected medicine is compounded glutathione injection, labeled at 200 mg/mL and supplied in 10 mL multidose vials. Greenwich Rx identifies the recalled lots by numbers beginning with 0060 and lists beyond-use dates from October 2 through November 12, 2026. The complete lot numbers are 0060-062426-1, 0060-062726-1, 0060-070926-1, 0060-071426-1, 0060-071426-2, 0060-072026-1, 0060-072726-1, 0060-072926-1, 0060-073126-1 and 0060-080426-1.
The company says the affected products were distributed nationwide from June 26 to September 21, 2026, and were intended for subcutaneous injection. Greenwich Rx is notifying customers by mail. Customers with a vial from an affected lot are instructed to stop using it and follow the disposal directions in the company’s recall notice. The FDA page says the agency posted the company’s announcement as a public service; posting does not mean the FDA endorses the product or company.
Greenwich Rx says it has received two reports of emergency department care after patients received a glutathione product intravenously that was not formulated for IV administration. That account is from the company. The announcement does not establish that endotoxin exposure caused those patients’ reported care, nor does it provide further clinical details.
Risks From Injected Endotoxins
The recall concerns a product administered by injection, a route that can expose patients to risks different from those associated with medicines taken by mouth. Greenwich Rx warns that injectable products with elevated endotoxin levels could cause serious medical events, including fever, low blood pressure, inflammatory reactions, anaphylactic shock and death. These are risks cited in the company’s announcement, not a statement that every patient who received a recalled vial will experience harm.
The reported emergency visits add urgency to the company’s instructions to stop using affected vials, but the circumstances matter: Greenwich Rx links those reports to intravenous use of a product not formulated for IV use. The announcement does not say that the patients used one of the recalled lots or that endotoxin levels were responsible. Patients and clinicians should rely on the product label and recall notice and contact a qualified healthcare professional about individual health concerns.
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Recall Lots and Distribution Dates
The FDA posted the recall under its section for company announcements. The notice identifies Greenwich Rx as a 503A compounding pharmacy and says the company is conducting the recall with the FDA’s knowledge. The FDA’s posting is a public-service publication of the company’s notice; the agency states that it does not endorse the company or product.
Glutathione is described in the announcement as a naturally occurring antioxidant that helps protect cells from oxidative stress. That description does not change the scope of this action: the recall is for specified lots of a compounded injectable product, not a general recall of all glutathione products. The listed beyond-use dates and lot numbers are the identifiers customers should compare with the vial and packaging.
Because the products went to patients nationwide over nearly three months, people who received glutathione from Greenwich Rx during the distribution period may need to check whether their vial is included. The notice directs customers to the product label for the location of the lot number and beyond-use date, and tells them to follow the written recall instructions rather than continue using an affected vial.
“The product is being recalled due to potential elevated endotoxin levels.”
— Greenwich Rx, in its recall announcement
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Patient Reports and Exposure Details
The announcement does not name the patients, describe their conditions, say when the emergency visits occurred or state whether they have recovered. It also does not identify whether the product involved in the two reports came from any of the 10 recalled lots. The company’s notice associates the reports with IV administration of a product not formulated for that route, but does not say that endotoxins caused the events.
The notice describes the concern as potential elevated endotoxin levels; it does not provide test results, the measured levels, or details about how many vials may be affected. It is also not clear how many patients received the recalled lots or how many have been contacted. The FDA page reproduces the company’s announcement and does not provide a separate agency assessment of the reported cases.
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Check Vials and Follow Recall Instructions
Customers who received glutathione from Greenwich Rx should compare the vial’s lot number and beyond-use date with the recalled list. If a vial matches, the company says to stop using it and follow disposal instructions in the recall notification. It advises anyone who believes they have experienced a health issue related to the product to contact a healthcare provider. This is not a diagnosis or a substitute for professional medical advice.
Questions about the recall can be directed to Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com, Monday through Friday from 8 a.m. to 5 p.m. Eastern Time. Greenwich Rx also says suspected adverse reactions or product-quality problems may be reported to the FDA’s MedWatch program online or by mail or fax. Further information about the number of affected products, the reported patient cases and any additional recall steps was not included in the October 1 announcement.
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Key Questions
Which Greenwich Rx glutathione products are included in the recall?
The recall covers 200 mg/mL compounded glutathione in 10 mL multidose vials intended for subcutaneous injection, from the 10 lot numbers listed in the company announcement. Check the vial and packaging against the full lot list and beyond-use dates in the recall notice.
Why is Greenwich Rx recalling the product?
The company says the affected lots may have elevated endotoxin levels. It warns that injectable products with elevated levels could cause serious medical events, but the notice does not say every vial is affected or that every recipient will become ill.
What should a customer do with a recalled vial?
Greenwich Rx instructs customers to stop using the product and follow the disposal directions in the recall notification. People with health concerns should contact a healthcare provider.
Were the two emergency department cases caused by endotoxins?
The announcement does not establish that. Greenwich Rx reported two cases after IV administration of a product not formulated for IV use, but did not provide details linking the cases to endotoxin exposure or confirming that the product came from a recalled lot.
How can customers ask questions or report a problem?
Customers can contact Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com, Monday through Friday, 8 a.m. to 5 p.m. Eastern Time. The company also points customers to the FDA’s MedWatch program for reporting adverse reactions or product-quality problems.
Source: primary
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