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Greenwich Rx announced a voluntary nationwide recall of 10 lots of compounded glutathione injection after identifying potential elevated endotoxin levels. The pharmacy says it has received two reports of patients needing emergency department care after IV use of a glutathione product not formulated for that route; the recall affects product intended for subcutaneous injection.
Greenwich Rx is voluntarily recalling specific lots of its compounded glutathione injection nationwide because they may contain elevated endotoxin levels, according to a company notice posted by the U.S. Food and Drug Administration on October 1, 2026. The pharmacy says the recalled product was intended for subcutaneous injection and that it has received two reports of patients receiving emergency department care after intravenous use of a glutathione product not formulated for IV administration.
The recall covers 10 lots of glutathione injection at a strength of 200 mg/mL, packaged in 10 mL multidose vials. Greenwich Rx says the lots were distributed to patients nationwide from June 26 to September 21, 2026. The company announcement lists these lot numbers and beyond-use dates: 0060-062426-1, October 2, 2026; 0060-062726-1, October 5; 0060-070926-1, October 17; 0060-071426-1 and 0060-071426-2, October 22; 0060-072026-1, October 28; 0060-072726-1, November 4; 0060-072926-1, November 6; 0060-073126-1, November 8; and 0060-080426-1, November 12.
Greenwich Rx says customers who received product from an affected lot should stop using it and follow the disposal instructions in the recall notification. The company is contacting customers by mail. Patients who think they may have experienced a health problem related to the product are advised to contact a healthcare provider. The notice directs customers with questions to Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com, Monday through Friday, 8 a.m. to 5 p.m. Eastern time.
The company’s notice identifies potential endotoxin contamination as the reason for the recall. It warns that injectable products with elevated endotoxin levels could cause serious medical events, including fever, low blood pressure, inflammatory reactions, anaphylactic shock and death. Those are risks cited in the notice; it does not say that every recalled vial contains elevated endotoxin or that every recipient will become ill.
Risks From Injectable Contamination
The recall matters because the product is an injectable medication, and the company’s warning describes potentially severe reactions if an injectable product has elevated endotoxin levels. Patients who have a vial at home may not be able to determine its status by appearance, so identifying the exact lot number and beyond-use date is central to following the recall instructions.
The notice also distinguishes the recalled product’s intended route from the IV use mentioned in two patient reports. Greenwich Rx says the affected glutathione was intended for subcutaneous injection; it reports that the two patients received emergency care after IV administration of a glutathione product not formulated for IV use. The announcement does not establish that the recalled lots caused those events, or that endotoxin exposure was responsible. Readers should not interpret the reports as proof of a confirmed causal link.
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Lots and Distribution Dates
Greenwich Rx describes itself as a 503A compounding pharmacy. Compounded medications are prepared by a pharmacy for patients rather than supplied as standard mass-produced products. The FDA page carrying this notice labels it a company announcement and says the agency posts company recall notices as a public service; it also states that posting does not mean the FDA endorses the company or product.
The company says the affected glutathione was dispensed in 10 mL multidose vials and distributed across the United States during the three-month period ending September 21. Customers should compare the lot number and beyond-use date on their product label with the list in the notice, rather than relying only on the product name or strength. The announcement says product photographs show where to find those details on the label.
“The product is being recalled due to potential elevated endotoxin levels.”
— Greenwich Rx, in its recall announcement
What the Notice Does Not Establish
The announcement does not state whether testing confirmed elevated endotoxin in every affected lot, how many vials were distributed, or how many remain with patients. It also does not provide details about the two patients, their outcomes, or whether their emergency visits were linked to endotoxin exposure. The company describes the reports in connection with IV administration of a product not formulated for that route, but does not say whether those patients used one of the recalled lots.
The notice provides no estimate of the number of people who may have used the product or the rate of adverse events. The FDA’s role, as described on its page, is to post the company announcement; that posting should not be read as an independent FDA finding about the product or the reported cases.
Customer Notices and Safety Reports
Greenwich Rx says it is notifying customers by mail and instructs recipients of the affected lots to discontinue use and follow the disposal directions included in the notice. Customers who need help identifying a recalled vial or understanding the instructions can contact Sedgwick by phone at (866) 552-4916 or email at GreenwichRx7542@sedgwick.com during the stated weekday hours.
Patients who believe they have had a health issue related to the product should contact a healthcare provider. The company notice also directs consumers and health professionals to report adverse reactions or quality problems to the FDA’s MedWatch program online, by mail or by fax. The announcement does not give a deadline for completing the recall or describe any further investigation milestones.
Key Questions
Which Greenwich Rx glutathione products are included in the recall?
The recall covers 10 listed lots of compounded glutathione injection, strength 200 mg/mL, in 10 mL multidose vials. Check the product label’s lot number and beyond-use date against the list in the company announcement.
What should customers do if they have one of the recalled lots?
Greenwich Rx says to stop using the product and follow the disposal instructions sent in the recall notification. Contact Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com with recall questions.
Why is the product being recalled?
The stated reason is potential elevated endotoxin levels. The notice warns of possible serious reactions from injectable products with elevated endotoxin, but does not say that every recalled vial has been confirmed to contain elevated levels.
Have patients been reported to have health problems?
Greenwich Rx reports two cases involving emergency department care after IV administration of a glutathione product that was not formulated for IV use. The notice does not establish whether the product was from a recalled lot or whether endotoxin caused the reported events.
Where can a possible adverse reaction be reported?
The notice advises patients to contact a healthcare provider about a possible health issue and says adverse reactions or quality problems may be reported to the FDA’s MedWatch program online, by mail or by fax.
Source: primary
