PV Bulletin

FDA Prohibits Use of Dietary Supplement Grade Glutathione in Injectables

FDA reminds compounders that dietary supplement grade glutathione is not suitable for injectable drugs, following reports of adverse events linked to contaminated products.

Primary source: MedWatch: The FDA Safety Information and Adverse Event Reporting Program

PV Impact Brief

Urgency: HighConfidence: high

What changed

Compounders are mandated to stop using dietary supplement grade glutathione for compounding injectable drugs due to associated patient safety risks.

Why it matters

This prohibition is crucial as the use of inappropriate ingredients can result in severe adverse events, including shock and symptoms consistent with sepsis-like conditions, highlighting significant patient safety concerns within compounded drugs.

Action needed

Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Signal Management
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Aug 27, 2026

Full briefing

Practical implication

Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

The FDA has issued a reminder to compounding pharmacies to refrain from using dietary supplement grade glutathione for injectable preparations. This is in response to reports of adverse events among patients who received intravenous glutathione, indicating serious health risks associated with elevated endotoxin levels in these products. Compounders must ensure that all components for injectable drugs are appropriate for their use, avoiding contaminants that could led to harmful effects.

What changed: Compounders are mandated to stop using dietary supplement grade glutathione for compounding injectable drugs due to associated patient safety risks.

Why it matters: This prohibition is crucial as the use of inappropriate ingredients can result in severe adverse events, including shock and symptoms consistent with sepsis-like conditions, highlighting significant patient safety concerns within compounded drugs.

Practical implication: Compounding pharmacies must verify that all components used in injectable drugs are suitable for their intended use and discontinue the use of any glutathione labeled for dietary supplement purposes, particularly if sourced from Medisca.

View original source

  • Source: FDA - What's New Drugs RSS
  • Published at source: 2026-08-27T00:00:00.000Z
  • Discovered by monitor: 2026-08-27T21:41:39.929Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signal#Safety Signals#Source-ingestion#Regulator-monitor#Usa#Fda.gov

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