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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 not formulated for IV administration.
Greenwich Rx is voluntarily recalling 10 lots of compounded glutathione injection distributed nationwide after identifying the potential for elevated endotoxin levels, according to a company announcement posted by the U.S. Food and Drug Administration on October 1, 2026. The company said the affected product was intended for subcutaneous injection and that it had received two reports involving emergency department care after patients received a glutathione product intravenously that was not formulated for IV use.
The recall covers glutathione injection at 200 mg/mL, supplied in 10-milliliter multidose vials and labeled for subcutaneous injection. The affected 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. Their beyond-use dates range from October 2 to November 12, 2026.
Greenwich Rx said the lots were distributed to patients nationwide between June 26 and September 21, 2026. The FDA notice identifies this as a company announcement and says the recall is being conducted with the agency’s knowledge; the agency also states that posting a company announcement does not constitute an endorsement of the product or company.
The company is notifying customers by mail. People who received a vial from an affected lot should stop using it and follow the disposal instructions in the recall notice. The company advises anyone who believes they have experienced a health issue related to the product to contact a healthcare provider. Questions can be directed to Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com, Monday through Friday, 8 a.m. to 5 p.m. Eastern Time.
Risks From Endotoxin Exposure
The recall concerns a product intended to be injected, so the stated quality concern has direct safety implications for people who may still have affected vials. Greenwich Rx says injectable products with elevated endotoxin levels could cause fever, low blood pressure and inflammatory reactions, as well as anaphylactic shock or death. These are risks described in the company’s notice, not confirmation that every recalled vial is contaminated or that any particular patient has experienced these outcomes.
The company also disclosed two reports of emergency department care after IV administration of a glutathione product it says was not formulated for that route. The notice does not establish that those reports involved the recalled lots or that elevated endotoxin levels caused the events. The distinction matters: the recall is tied to a potential product-quality issue, while the reports concern IV use of a product not formulated for IV administration.
For patients, the lot number and beyond-use date are the practical identifiers. A nationwide distribution window means recipients may be located across the country, and checking the label can help determine whether a vial falls within the recall. Anyone uncertain about a product’s lot or disposal directions can contact the recall line or their healthcare provider rather than use the vial.
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Affected Lots And Distribution
Greenwich Rx describes itself in the announcement as a 503A compounding pharmacy. The FDA notice lists the product as compounded glutathione injection, with a labeled strength of 200 mg/mL and a 10-milliliter multidose vial intended for subcutaneous injection. The company’s announcement says the recall is being carried out to the consumer level, meaning customers who received affected product are being contacted directly.
The dates printed on the affected lots’ labels are called beyond-use dates. They fall between October 2 and November 12, 2026, but the recall applies by lot number, not only by date. The distribution period given by the company—June 26 through September 21, 2026—describes when the lots went to patients, not when the product was used.
The FDA says it posts company recall announcements as a public service. In this case, the agency’s notice reproduces Greenwich Rx’s announcement and states that the recall is being conducted with FDA knowledge. It does not provide a separate agency finding about the source of the potential endotoxin issue.
“The product is being recalled due to potential elevated endotoxin levels.”
— Greenwich Rx, in its October 1 recall announcement
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What The Notice Does Not Establish
The notice identifies potential elevated endotoxin levels, but does not state the measured levels, how many vials may be affected, or what testing found. It also does not explain how the potential issue arose or whether it is limited to the listed lots. The FDA posting does not include a separate agency account of the investigation.
Greenwich Rx reports two emergency department cases following IV administration of a glutathione product not formulated for IV use. The announcement does not identify the patients, specify the medical events, say whether the product came from the recalled lots, or link the care to endotoxin exposure. It also does not report a number of confirmed injuries caused by the recalled product.
The company’s notice does not give a date when the recall will be completed or say whether additional lots could be included. Those details may depend on the company’s follow-up and any further information made public by regulators.
glutathione subcutaneous injection
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Customer Notices And Safety Reports
Greenwich Rx says it is contacting customers by mail and directs recipients of affected lots to stop using the product and follow the disposal instructions supplied with the recall notice. Customers can ask questions through Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com during the listed weekday hours.
People who believe they have experienced a health problem related to the product should contact a healthcare provider, according to the company. Adverse reactions or quality problems can also be reported to the FDA’s MedWatch program online, by mail or by fax, using the contact details in the agency notice. The announcement does not set out a further public update schedule, so any additional findings or changes to the affected-lot list remain to be seen.
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Key Questions
Which Greenwich Rx glutathione products are included in the recall?
The recall covers 10 listed lots of 200 mg/mL compounded glutathione injection in 10-milliliter multidose vials, labeled for subcutaneous injection. Check the vial’s lot number against the list in the recall notice; the affected beyond-use dates range from October 2 to November 12, 2026.
What should someone do if they have an affected vial?
Greenwich Rx says to stop using the product and follow the disposal instructions in the recall notification. Contact the company’s recall representative with questions. If you believe you have a health issue related to the product, contact a healthcare provider.
Why is the product being recalled?
The company says the lots may have elevated endotoxin levels. Greenwich Rx warns that injectable products with elevated endotoxin levels could cause serious medical events. The notice does not give test results or say that every vial is affected.
Were patients harmed by the recalled lots?
The company reports two emergency department-care reports after IV use of a glutathione product that was not formulated for IV administration. Its notice does not confirm that those cases involved the recalled lots or establish that endotoxin exposure caused the events.
How can patients ask questions or report a problem?
Questions 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. The FDA notice also provides instructions for reporting adverse reactions or quality problems to its MedWatch program.
Source: primary
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