Injectable glutathione is being recalled for endotoxin. In its small placebo-controlled trials for skin and Parkinson's, it did not beat placebo.

Why this note exists

Glutathione is a three-amino-acid peptide the body makes on its own. CDC notes that in the U.S. it is sold as an oral supplement promoted "for purposes such as skin brightening, immune support, detoxification, and increased energy."[2] Since August, at least four compounding pharmacies have recalled injectable glutathione, FDA has warned compounders about the ingredient, and CDC has opened an investigation.[1][2][3][4][5][6]

This note sets out what the agencies and pharmacies have actually said, how glutathione can legally be compounded at all, and what the controlled human trials of injected glutathione found. Every status below was checked on October 12, 2026.

The 2026 cluster

Supplement-grade powder, one lot, at least 30 patients

On August 27, 2026, FDA said it was "aware of reports of at least 30 patients who experienced adverse events following the administration of intravenous (IV) glutathione alone or in combination with other ingredients." The glutathione was compounded by different pharmacies, "all of which obtained their glutathione (Lot #229536) from Medisca Inc.," and it "was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs."[1] Reported events included "fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms, with some resulting in hospitalizations." Medisca told FDA on August 20 that it had warned its U.S. customers not to use the material in injectables.[1]

CDC's page, updated in mid-September, says the Texas Department of State Health Services alerted it in July to patients who fell ill after IV glutathione at an outpatient wellness clinic. CDC has since received reports of "over 25 people becoming sick in at least four states: Texas, Washington, Florida, and New York." At least three were hospitalized, all after IV doses, and one needed intensive care "including treatment for shock and abnormal blood clotting." Patients had received glutathione by vein, under the skin or into muscle.[2] CDC says all injections linked to these illnesses so far were made "using glutathione ingredients intended for use in dietary supplements."[2]

Company announcements posted on FDA's recalls page.[3][4][5][6] These are the four pepmg found by searching FDA and news coverage on October 12, 2026; it is not an exhaustive database count.

The four notices differ in what they say. Victory and Optimal Balance cite pharmacy testing that "identified elevated bacterial endotoxin levels"; Centric says its products were "compounded with a Glutathione API containing elevated endotoxin levels."[3][4][5] Greenwich Rx describes "potential elevated endotoxin levels" in vials "intended for subcutaneous injection," and reports two patients who needed emergency care after IV use "of a glutathione product that was not formulated for IV use."[6] Neither the Centric nor the Greenwich notice names its supplier, and CDC's page, which lists the first three recalls, predates Greenwich's.[2][5][6] FDA's enforcement data, queried October 12, classify the Victory and Optimal Balance recalls as Class I; the other two had no enforcement entry yet.[7]

Not the first time

The same failure in 2015 and 2019

In 2019 FDA warned compounders about glutathione powder repackaged by Letco Medical and labeled "Caution: Dietary Supplement." Seven patients at one outpatient clinic each received 1,400 mg by IV and, within minutes, had nausea, vomiting, chills, body aches and lightheadedness; one, with low blood pressure and difficulty breathing, was transferred to a hospital. FDA's laboratory found every powder sample it tested had excessive endotoxin, "some results as high as five times the appropriate limit."[8]

Before that, Australian public health officials reported seven cases of probable endotoxin poisoning linked to contaminated compounded glutathione infusions, five of them in people using the infusions for Lyme disease.[9] CDC dates that outbreak to 2015.[2] FDA's 2026 notice says the agency "remains concerned about continued risks to patients."[1]

The regulatory record

Not approved, compounded under an interim policy

CDC states plainly: "There are no FDA-approved glutathione products in the United States."[2] An openFDA query of Drugs@FDA on October 12 found glutathione only as glutathione disulfide, an ingredient of eye-surgery irrigating solutions such as BSS PLUS.[12]

Pharmacies can compound it anyway because of where FDA has put it. FDA's list of 503A nominations, updated May 14, 2026, places glutathione in category 1, "Bulk Drug Substances Under Evaluation."[10] Under FDA's interim policy, the agency "does not intend to take regulatory action" against 503A compounding with such a substance "if, among other conditions, the bulk drug substance appears on Category 1."[11] Category 1 is not an approval and not a finding of safety or effectiveness; it is an interim status while FDA evaluates the nomination.

The same policy sets conditions on the ingredient itself. A bulk substance used in 503A compounding must be made by an FDA-registered establishment and "accompanied by a valid certificate of analysis," and FDA "does not consider USP monographs for dietary supplements to be applicable" monographs for this purpose.[11] FDA's 2026 notice adds that compounders "should not rely on testing alone" to ensure quality.[1]

The human evidence

The placebo-controlled trials for skin, Parkinson's and depression are small, and none beat placebo

Skin lightening. The only placebo-controlled IV study that a 2025 systematic review found was a 2016 study from Multan, Pakistan.[17] Women received a 1,200 mg glutathione injection product that also contained vitamin C, twice weekly for six weeks, or IV saline. Of 50 enrolled, 32 finished. Six of 16 on glutathione improved against three of 16 on placebo, p = 0.054, and at six months only one patient kept the improvement.[14] Eight glutathione patients developed abnormal liver tests and one had anaphylactic shock; they were excluded from the analysis along with their controls.[14] The review concluded that "IV glutathione is contraindicated due to lack of efficacy and side effects," while finding that oral glutathione lowered the melanin index against placebo in five randomized trials.[17] A July 2026 review called the evidence "too limited to justify routine use for cosmetic skin lightening" and noted that routine co-administration of vitamin C makes glutathione's own effect hard to isolate.[18]

Parkinson's disease. In a 2009 double-blind pilot, 21 people whose motor symptoms were not adequately controlled by their medicines received 1,400 mg IV glutathione or placebo three times a week for four weeks. Motor and daily-living scores improved by a mean of 2.8 points more on glutathione, P = 0.32, and over the next eight weeks worsened by 3.5 points more, P = 0.54; the authors found no safety concerns.[13] A 2017 phase IIb trial gave 45 people intranasal glutathione, 100 or 200 mg three times daily, or saline for three months. All groups improved, including placebo, and neither dose was superior to placebo; one person on the higher dose developed cardiomyopathy.[15]

Depression. A 2024 double-blind study of 30 patients added IV glutathione or saline to ketamine infusions. Both groups improved, with no statistically significant difference between them.[16]

From the study abstracts.[13][14][15][16] Trials this small can miss a modest effect; these did not show one.

The other side

Two hospital trials did report benefits

Injected glutathione is not inert in every trial. In a 2002 double-blind trial, 52 colorectal cancer patients received glutathione, 1,500 mg per square meter of body surface, infused before oxaliplatin chemotherapy, or saline. In the abstract's eight-cycle results, grade 2 to 4 nerve damage occurred in 2 patients on glutathione against 11 on placebo, P = .003, and tumor response rates were similar.[19]

In a 2021 trial of 100 heart attack patients undergoing emergency angioplasty, 2,500 mg glutathione infusions before the procedure and at 24, 48 and 72 hours significantly reduced inflammation markers and the release of troponin T, a marker of heart muscle injury, compared with placebo.[20] Those are biomarker outcomes in a hospital population. Neither trial tested the skin, detox, energy or immune uses CDC says glutathione is promoted for, and both were run in hospital patients receiving chemotherapy or emergency heart care.

Three things this note is not saying

It is not saying glutathione itself caused the 2026 illnesses. FDA says the symptoms are consistent with excessive endotoxin, and CDC says the illnesses are likely linked to it.[1][2]

It is not saying every compounded glutathione vial is contaminated. The recalls name specific lots, and the investigation is ongoing; CDC says the case count "may change as more information becomes available."[2]

It is not saying glutathione has no effect anywhere. Two hospital trials reported benefits, and oral glutathione has small positive skin trials.[17][19][20] What it is saying is that the placebo-controlled trials of injected glutathione for skin lightening and Parkinson's disease were small and did not beat placebo, while injectable glutathione made from supplement-grade powder has a repeating contamination record.

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