FDA Warns Compounders on Glutathione After 30 Adverse Events

Thirty patients have experienced adverse events linked to IV glutathione compounded from dietary supplement grade ingredient, and the FDA's August 27 communication makes clear that supplier qualification failures sit at the center of the problem. All implicated pharmacies sourced glutathione Lot #229536 from Medisca Inc., headquartered in Plattsburgh, N.Y., underscoring how a single upstream sourcing decision can propagate patient risk across multiple compounding sites.

Reported adverse events include fever, chills, dizziness, pain, and sepsis-like symptoms consistent with excessive endotoxin exposure. Hospitalizations have been confirmed. Two Texas-based pharmacies have initiated recalls tied to elevated endotoxin levels in their glutathione injectable products. Endotoxin contamination at injectable concentrations can also cause hypotension and, in severe cases, death.

Medisca notified the agency on August 20, 2026, that it had issued a customer warning against using its dietary supplement grade glutathione in injectable compounding. FDA is urging any compounder that received the implicated material to contact patients immediately and instruct discontinuation of the IV product. The agency continues to receive adverse event reports and has an active investigation underway.

The regulatory position is unambiguous: dietary supplement grade ingredients carry no assurance of the purity, endotoxin control, or sterility specifications required under 21 CFR Part 211 for injectable drug manufacturing. FDA explicitly states that quality must be built into every stage of the compounding process, including ingredient sourcing, stock solution preparation, and finished product release. End-product testing alone is insufficient to compensate for an ingredient sourced outside pharmaceutical-grade supply chains.

For QA directors and regulatory leads, the compliance read connects directly to supplier qualification programs. FDA's guidance calls on compounders to verify that all APIs and excipients are manufactured under conditions appropriate for the intended route of administration. The agency also directs API suppliers, relabelers, and repackagers to include explicit statements on labels and certificates of analysis (COAs) identifying the upstream manufacturer and specifying appropriate and inappropriate uses for each ingredient. This is not a new position: FDA issued a comparable communication on dietary ingredient glutathione for injectable compounding in 2019, making the recurrence a documented pattern rather than an isolated incident.

Adverse events should be submitted through FDA's MedWatch program, either online or by fax at 1-800-FDA-0178.

With the investigation ongoing and adverse event reports still incoming, compounders holding any Medisca dietary supplement grade glutathione inventory face an immediate supplier qualification and patient notification checkpoint.

Source: FDA Human Drug Compounding via FDA.gov, August 27, 2026.