Adverse effect · Glutathione

How common is endotoxin reactions from compounded injectables with Glutathione?

B
Grade B — probable, not settledFDA case series (≥30 patients); recalls · effect size: moderate · adverse
Short answerProbable, not settled. Human data exist (FDA case series (≥30 patients); recalls) and mostly agree, showing a moderate effect — but too few, too small, or not yet peer-reviewed for a firm answer. On 27 August 2026 the FDA reported at least 30 patients with fever, chills, pain, dizziness and shock-like symptoms after intravenous glutathione compounded from dietary-supplement-grade material, some hospitalised, and judged the picture consistent with excess endotoxin. A nationwide recall of affected lots followed in September, with nine further reports, and on 1 October 2026 another compounding pharmacy recalled ten lots after two patients needed emergency care; both had been given intravenously a product made for injection under the skin. Not a trial, but a regulator-verified harm signal for the injectable route.

What the studies show

On 27 August 2026 the FDA reported at least 30 patients with fever, chills, pain, dizziness and shock-like symptoms after intravenous glutathione compounded from dietary-supplement-grade material, some hospitalised, and judged the picture consistent with excess endotoxin. A nationwide recall of affected lots followed in September, with nine further reports, and on 1 October 2026 another compounding pharmacy recalled ten lots after two patients needed emergency care; both had been given intravenously a product made for injection under the skin. Not a trial, but a regulator-verified harm signal for the injectable route.

Human trials exist and mostly agree, but there are too few of them, they are too small, or one big one is still reading out. Expect the grade to move.

  1. 1
    FDA. FDA reminds compounders not to use dietary supplement-grade glutathione in injectables.FDA statement, 27 Aug 2026At least 30 patients; symptoms consistent with excessive endotoxin; some hospitalised.
  2. 2
    FDA. Nationwide recall of compounded glutathione injectables and two blends due to elevated endotoxin levels.FDA recall notice, posted 13 Sep 2026Three glutathione 200 mg/mL lots plus blends made with the same material; nine reports of fever, chills, chest pain, nausea, headache or malaise.
  3. 3
    FDA. Voluntary nationwide recall of compounded glutathione injection due to potential elevated endotoxin levels (company announcement).FDA recall notice, 1 Oct 2026Ten lots of glutathione 200 mg/mL, distributed 26 June to 21 September 2026; two reports of emergency care after intravenous use of a product intended for subcutaneous injection.

In context

Glutathione is a three-amino-acid molecule every cell makes and uses to handle oxidative stress. It is sold orally and, in some countries, intravenously for skin lightening. Systematic reviews of the small trials find it may brighten sun-exposed skin slightly, but call the evidence inconclusive because the studies are few, small and inconsistent. Oral absorption is itself questionable, and the intravenous use that carries the most risk has the least evidence — in 2026 the FDA linked at least 30 adverse events, some needing hospital care, to injectables compounded from supplement-grade glutathione contaminated with endotoxin.

Glutathione is supplement; injectable use unapproved. Legal status differs by country — see the regulation section or the jurisdiction pages.

Questions

Is Glutathione proven to cause endotoxin reactions from compounded injectables?
Not yet settled. FDA case series (≥30 patients); recalls — LYO grades it B, meaning probable but liable to change as trials read out.
What studies are behind the grade?
On 27 August 2026 the FDA reported at least 30 patients with fever, chills, pain, dizziness and shock-like symptoms after intravenous glutathione compounded from dietary-supplement-grade material, some hospitalised, and judged the picture consistent with excess endotoxin. A nationwide recall of affected lots followed in September, with nine further reports, and on 1 October 2026 another compounding pharmacy recalled ten lots after two patients needed emergency care; both had been given intravenously a product made for injection under the skin. Not a trial, but a regulator-verified harm signal for the injectable route.
Is Glutathione approved for this?
No. Glutathione is supplement; injectable use unapproved; it is not an approved medicine for any indication in the jurisdictions LYO covers.

Other outcomes for Glutathione

Written and maintained by LYO Research — how pages are written and checked. Reviewed 7 October 2026. Grades count human evidence only; see how LYO grades. Not medical advice. Correct this page →