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Greenwich Rx announced a voluntary nationwide recall of 10 lots of compounded glutathione injections because of potential elevated endotoxin levels. The company says two patients received emergency department care after intravenous use of a glutathione product not formulated for IV administration; it has not said whether those cases involved recalled lots or were caused by endotoxin exposure.
Greenwich Rx is voluntarily recalling 10 lots of compounded glutathione injection distributed nationwide after identifying potential elevated endotoxin levels, according to a company announcement posted by the U.S. Food and Drug Administration on October 1, 2026. The recall concerns 200 mg/mL product in 10 mL multidose vials intended for subcutaneous injection, and the company is asking customers with affected lots to stop using them.
The recall covers lots 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 listed beyond-use dates run from October 2 through November 12, 2026. The product was distributed to patients nationwide between June 26 and September 21, 2026.
Greenwich Rx said injectable products with elevated endotoxin levels could cause serious medical events, including fever, low blood pressure, inflammatory reactions, anaphylactic shock and death. Those outcomes are risks described in the company’s announcement; the notice does not say that every patient who used a recalled vial will experience an adverse effect.
The company reported receiving two reports of patients needing emergency department care after intravenous administration of a glutathione product that was not formulated for IV use. The announcement does not identify those patients, establish whether their product came from a recalled lot, or say that endotoxin exposure caused the reported events. The recalled vials were labeled for subcutaneous injection, not intravenous use.
Greenwich Rx said it is notifying customers by mail. People who received one of the listed lots should stop using the product and follow the disposal instructions in the recall notice. Anyone who believes they have experienced a health problem related to the product should 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 for Patients With Recalled Vials
The recall concerns an injectable compounded drug, so patients and healthcare providers need to identify the specific lot before deciding whether a vial is affected. Endotoxins can trigger serious reactions when present in injectable products, according to the company’s risk statement. The stated possibility of severe outcomes makes the stop-use instruction important, even though the notice does not establish that any particular patient has been harmed by endotoxin in these lots.
The announcement also draws attention to the difference between the product’s labeled route and the reported IV use. Greenwich Rx said the recalled glutathione was intended for subcutaneous injection, while the two emergency-care reports involved IV administration of a product not formulated for that route. Patients should not infer from the notice that these routes are interchangeable; questions about use or a possible exposure should be addressed with a healthcare provider.
Because the pharmacy says the product went to patients across the country, affected customers may need to check packaging or the vial label rather than rely only on the product name. The lot number and beyond-use date are the key details supplied for matching a vial to the recall. The company directs customers to its mailed notification for disposal instructions and contact information.
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How to Identify Affected Lots
The FDA page describes this as a company announcement posted as a public service. It says the FDA does not endorse the product or company. Greenwich Rx, identified in the announcement as a 503A compounding pharmacy, said the recall is being conducted with the knowledge of the FDA. The notice does not describe an FDA finding that the product caused the reported emergency visits.
The affected product is listed as Greenwich Rx’s compounded glutathione injection, at 200 mg/mL in 10 mL multidose vials. The announcement gives ten lot numbers and corresponding beyond-use dates; customers should compare those details with the product label. The listed dates are not a substitute for checking the lot number, since the recall is defined by the specified lots.
Greenwich Rx said the product was distributed over a nearly three-month period, from June 26 through September 21, 2026. Its announcement is dated October 1, 2026, the same date shown as the FDA publish date. No broader recall of all glutathione products is described in the notice; the action applies to the specific lots listed by the company.
“The product is being recalled due to potential elevated endotoxin levels.”
— Greenwich Rx, in its company announcement
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What the Recall Notice Does Not Establish
The announcement does not say how many vials or patients are affected, how many customers have been contacted, or how the potential elevated endotoxin levels were identified. It does not provide test results, explain whether all ten lots share the same issue, or state whether the company has determined the source of the potential contamination.
The relationship between the two emergency department reports and the recall also remains unclear. Greenwich Rx says the patients received a glutathione product intravenously that was not formulated for IV use, but the notice does not confirm whether that product was from one of the ten recalled lots. It also does not attribute those events to elevated endotoxin levels or provide details about the patients’ conditions or outcomes.
The FDA posting republishes the company’s announcement and explicitly says it does not endorse the company or product. The notice states that the recall is being conducted with FDA knowledge, but it does not describe an independent agency investigation or a final determination about the product’s safety.
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Customer Notices and Safety Reports
Greenwich Rx says it is contacting customers by mail. People with potentially affected vials should compare the package label with the ten listed lot numbers, stop using a matching product, and follow the disposal instructions in the recall notification. The company says customers can contact Sedgwick at (866) 552-4916 or GreenwichRx7542@sedgwick.com on weekdays from 8 a.m. to 5 p.m. Eastern time.
Patients who think they have experienced a health problem related to the product should contact a healthcare provider, the company advises. Adverse reactions or product-quality problems may also be reported to the FDA’s MedWatch program online, by mail or by fax, using the reporting options listed in the agency’s notice.
The announcement does not give a date for further updates or say whether additional lots may be added. Readers should rely on the company’s recall notice and subsequent FDA postings for any revised lot information or new safety details.
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Key Questions
Which Greenwich Rx glutathione products are included in the recall?
The recall covers 10 specified lots of compounded glutathione injection at 200 mg/mL in 10 mL multidose vials. The 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. Check the vial label against the company’s full notice.
What should a patient do if they have a recalled vial?
Greenwich Rx says to stop using the product and follow the disposal instructions provided in its recall notification. Contact a healthcare provider about a health concern, and contact Sedgwick or Greenwich Rx with recall questions.
Why is the glutathione being recalled?
The company says the lots are being recalled because of potential elevated endotoxin levels. Its announcement warns that injectable products with elevated endotoxins could cause serious reactions, but it does not say that all patients who used the lots will become ill.
Were the two reported emergency visits caused by the recalled product?
The announcement does not establish that. Greenwich Rx reported two emergency department visits after IV administration of a glutathione product not formulated for IV use, but it does not say whether those products were from the recalled lots or whether endotoxins caused the events.
How can someone report an adverse reaction?
Contact a healthcare provider about a possible health problem. The company notice also directs patients and others to report adverse reactions or product-quality concerns to the FDA’s MedWatch program online, by mail or by fax.
Source: primary
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