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FDA Warns Compounders: Supplement-Grade Glutathione Does Not Belong in Injections

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Quick answer: On August 27, 2026, the FDA told compounding pharmacies not to use dietary supplement grade glutathione to make injectable drugs. The agency said it knew of at least 30 patients who had adverse events after IV glutathione, and that the pharmacies involved had all obtained their glutathione from one lot, #229536, supplied by Medisca Inc. Four Texas pharmacies have since recalled injectable glutathione. If you became ill after a glutathione IV or injection, call 817-870-2102.

What the FDA said

“The glutathione was labeled as dietary supplement grade, which is not an appropriate ingredient to make injectable drugs.”

U.S. Food and Drug Administration, August 27, 2026

According to the notice:

  • The FDA is aware of reports of at least 30 patients who experienced adverse events after intravenous glutathione, given alone or combined with other ingredients.
  • The glutathione was compounded by different pharmacies, all of which obtained it (Lot #229536) from Medisca Inc., whose U.S. headquarters is in Plattsburgh, New York.
  • Two pharmacies in Texas had conducted recalls related to elevated endotoxin levels in their glutathione injectable drugs.
  • Medisca told the agency on August 20, 2026 that it had sent its U.S. customers a warning not to use its dietary supplement grade glutathione in compounding injectable drugs.
  • The FDA says it continues to receive reports consistent with endotoxin exposure and is actively investigating.

The symptoms the FDA described

Reported adverse events included fever, chills, pain, dizziness, signs of shock, and sepsis-like symptoms, with some patients hospitalized. The FDA said these symptoms are consistent with exposure to excessive endotoxin levels, and that endotoxin exposure can also cause muscle pain, headache, nausea, vomiting, low blood pressure, and death.

Why “supplement grade” matters

An ingredient made for capsules or powders is swallowed and passes through the digestive system. An ingredient in an injection or IV goes into the body directly. The FDA’s notice says ingredients labeled for dietary supplement use may contain impurities and contaminants, including endotoxins, that may be harmful when given as an injectable drug.

The agency put the responsibility on the compounder. Its notice says compounders are responsible for ensuring that every component of an injectable drug is appropriate for its intended use, should know their ingredient suppliers, and should not rely on testing alone to ensure quality.

Not the first warning

The notice also states that the FDA previously communicated in 2019 about the use of dietary ingredient glutathione for compounding injectable drugs, and that the agency remains concerned about continued risks to patients.

The CDC is investigating too

In a September 2026 update, the CDC said it had received reports of more than 25 people becoming sick in at least four states (Texas, Washington, Florida, and New York), with at least three hospitalized. It says the injections linked to these illnesses were made with glutathione ingredients intended for dietary supplements. More in our summary of the CDC investigation.

Four recalls so far

  • Victory Medical Center Pharmacy (Austin), August 5, 2026.
  • Optimal Balance Pharmacy (Houston), August 19, 2026.
  • Centric Compounding (Houston), September 11, 2026, including Myers’ Cocktail and Tri-Immune Boost.
  • Greenwich Rx (Tomball), October 1, 2026. Read more: Greenwich Rx glutathione recall.

The FDA notice does not name the two Texas pharmacies it refers to, and the Centric Compounding and Greenwich Rx recall announcements do not name their glutathione supplier. Every recalled lot is listed in our lot checker.

What this means if you were injured

When a contaminated ingredient moves from a supplier to a compounding pharmacy to a clinic to a patient, responsibility can extend to more than one company in that chain. The FDA’s findings are public and they are evidence, but each claim still depends on which product you received, which lot it came from, and what happened to you.

The FDA recommends that health care professionals check with their compounders about the source of the glutathione used for their patients. As a patient, you can ask your clinic the same question, in writing: which pharmacy made the product, and which lot.

The Law Offices of John David Hart has filed suit against Victory Medical Center Pharmacy in Travis County, Texas, and is reviewing claims from patients nationwide. Start with the full guide: Glutathione Recall Lawsuit, or call 817-870-2102 for a free case review. No fee unless we win.

Source: FDA, FDA reminds compounders not to use dietary supplement grade glutathione for injectables, August 27, 2026.

This article is general information about a public FDA notice and is not legal advice. Contacting the firm does not create an attorney-client relationship. Every case is different, and prior results do not guarantee a similar outcome.

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