Glutathione injection
Clinical reviewer: Jacob Moore, MD · Last checked September 16, 2026
What is a glutathione injection?
Glutathione injection is a compounded IV or IM product containing the antioxidant tripeptide glutathione, prepared by a 503A pharmacy from bulk glutathione powder. Glutathione sits in FDA's Category 1 compounding list, meaning it is still under evaluation, and the controlled human trial cited on this page tested an oral form, not an injectable one.
How is a glutathione injection made and sold?
Glutathione is the tripeptide glutamate-cysteine-glycine. An injectable version is a compounded drug: a 503A pharmacy prepares it from bulk glutathione powder rather than dispensing a manufactured, FDA-approved product. FDA lists glutathione in Category 1 of its bulk drug substances document, meaning the nomination has enough supporting information to be under evaluation, not that it has been added to the 503A bulks list [1].
Why did FDA flag glutathione injections in 2026?
FDA's August 27, 2026 reminder describes at least 30 patients who experienced adverse events after IV glutathione, including "fever, chills, pain, dizziness, signs of shock and sepsis-like symptoms," tied to dietary-supplement-grade material that can carry endotoxin impurities [2]. Days earlier, on August 19, 2026, Optimal Balance Pharmacy announced a voluntary nationwide recall of a Glutathione Injection lot for "elevated bacterial endotoxin levels," warning of possible fever, hypotension, anaphylactic shock and death [3]. The randomized controlled human trial cited here tested a 250 mg or 1,000 mg oral dose over six months, not an injectable form [4].
Related terms
Sources
- FDA — Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, updated May 14, 2026
- FDA reminds compounders not to use dietary-supplement-grade glutathione injectables (Aug 27, 2026)
- FDA — Optimal Balance Pharmacy voluntary nationwide recall of compounded Glutathione Injection (Aug 20, 2026)
- Richie JP Jr et al. Randomized controlled trial of oral glutathione supplementation. Eur J Nutr, 2015.
This entry is for education and is not medical advice. Talk with a licensed clinician about your own situation before starting, stopping, or changing any treatment.
