An October 2026 FDA announcement detailed Greenwich Rx’s recall of 10 compounded glutathione lots after two patients visited the emergency department. Earlier August and September recalls involved other pharmacies, reported adverse events, and elevated endotoxin concerns.
Multiple Company Recalls Highlight Endotoxin and Patient Safety Concerns
On October 1, 2026, the FDA announced a voluntary nationwide recall of 10 lots of compounded glutathione from Texas-based Greenwich Rx due to potentially elevated endotoxin levels. The recall followed reports that two patients required emergency department care after receiving the product intravenously, although it was intended for subcutaneous injection. The announcement followed three earlier 2026 recalls by other compounding pharmacies involving reported patient adverse events, providing broader context on compounded injectable drug quality and patient safety.
Details of Compounding Pharmacy Recalls of Injectable Glutathione
Between August and October 2026, the FDA published four voluntary recall announcements involving compounded injectable glutathione 200 mg/mL over elevated or potentially elevated endotoxin levels. Each recall involved a separate compounding pharmacy, with differences in affected lots, product formulations, and reported adverse events.
Greenwich Rx — October 2026
The Greenwich Rx recall covered 10 lots in 10 mL multidose vials distributed nationwide between June 26 and September 21. The Texas pharmacy reported that two patients required emergency department care after intravenous administration of a formulation intended for subcutaneous injection.
Centric Compounding — September 2026
Houston-based Centric Compounding recalled six lots across three injectable products, including glutathione, Myer’s Cocktail, and Tri-Immune Boost. The pharmacy identified elevated endotoxin levels in a glutathione ingredient used in the products and reported nine adverse events involving fever, chills, chest pain, nausea, vomiting, and headache.
Optimal Balance Pharmacy — August 2026
Testing identified elevated bacterial endotoxin levels in one lot of compounded glutathione distributed by Optimal Balance Pharmacy. The Houston pharmacy recalled the affected 30 mL multidose vials after receiving reports of fever, chills, headache, nausea, vomiting, and allergic-type symptoms.
Victory Medical Center Pharmacy — August 2026
The earliest announcement involved Victory Medical Center Pharmacy, which recalled three lots after testing identified elevated bacterial endotoxin levels. The Austin pharmacy reported adverse events including fever, chills, severe headache, nausea, vomiting, blood pressure changes, and injection-site reactions.
The CDC also identified the three August and September pharmacy recalls in its investigation of illnesses linked to injectable glutathione compounded with dietary-supplement-grade ingredients. The agency reported more than 25 illnesses across Texas, Washington, Florida, and New York, including at least three hospitalizations.
Drug Safety and Administration Considerations Following Compounded Glutathione Recalls
The recalled glutathione preparations are compounded injectable drug products that are not FDA-approved. In August 2026, the FDA warned against using dietary-supplement-grade glutathione to compound injectable drugs because these ingredients may contain impurities, including bacterial endotoxins, that are unsuitable for injection.
The FDA and CDC announcements documented several product safety findings and reporting considerations:
- Compounded drug quality and safety: The three August and September pharmacy recalls involved elevated endotoxin levels identified in products or ingredients.
- Administration route and intended use: Greenwich Rx reported two emergency department visits following intravenous administration of a formulation intended for subcutaneous injection.
- Adverse-event reporting: All four pharmacy recalls followed reports of adverse events, while the CDC documented illnesses and hospitalizations associated with its investigation.
Four voluntary recalls involved compounded injectable glutathione 200 mg/mL, with reported adverse events and potentially elevated endotoxin levels across the affected products.
The FDA accepts reports of suspected adverse reactions and drug quality problems through its MedWatch program. The CDC also directs healthcare providers to report suspected illness clusters associated with injectable glutathione to state or local health departments.
A 2026 Baxter sodium chloride injection recall documented another injectable product safety concern involving possible fiberglass particulate matter in two lots. State-level oversight also applies to Med Spa and IV therapy services, with requirements varying by jurisdiction. For example, Maine’s Chapter 15 rule establishes standards for patient evaluations, prescribing, medication preparation, and professional responsibilities in these settings.
For Med Spa and IV therapy operators, federal and state requirements address compounded drugs, product sourcing, and administration, with state-specific standards applying alongside federal regulations and product recall notices.
Practical Implications for Med Spas, Injectables, and IV Therapy Operators
- Assess applicable federal and state requirements for compounded injectable drugs, prescribing, and administration when evaluating services and suppliers.
- Monitor FDA recall announcements and follow pharmacy instructions for affected products.
- Document patient treatment details, including product lot numbers, routes of administration, and any reported adverse reactions.
- Maintain accurate product sourcing, inventory, and lot-tracking records to identify potentially affected supplies.
- Report suspected adverse reactions or product quality problems through the FDA’s MedWatch program, when applicable.
What to Watch Next
Further FDA recall updates and CDC investigation findings may provide additional information about affected products, reported illnesses, and potential safety concerns. For Med Spa and IV therapy operators, these developments may offer further insight into injectable drug safety and product quality concerns.
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Image Attribution: “FDA Sign & Bldg 21 at Entrance” by The U.S. Food and Drug Administration, via Wikimedia Commons, public domain.
