Centric Compounding LLC issued a nationwide recall of compounded intravenous products including Glutathione, Myer’s Cocktail, and Tri-Immune Boost in 30 mL multidose vials due to elevated endotoxin levels, the FDA announced Sept. 13. Endotoxins in intravenous products can cause high fever, dangerously low blood pressure, septic shock, and other life-threatening reactions.
The recalled products are compounded formulations widely used in wellness clinics and medical spas as intravenous infusion treatments marketed for immune support, detoxification, and general wellness purposes.
The recall is nationwide, meaning the affected products were distributed across all states. Healthcare providers who administered the products should identify and contact affected patients, the FDA said.
For the growing number of Americans who use IV wellness infusions, a market that has expanded rapidly through medical spas, concierge medicine practices, and wellness clinics, the recall underscores safety risks associated with compounded products that do not undergo the same manufacturing scrutiny as FDA-approved drugs.
Compounding pharmacies produce customized medications that are not commercially available, filling important medical needs. However, the compounding industry has faced recurring quality control issues, most notably the 2012 New England Compounding Center meningitis outbreak that killed 76 people and sickened hundreds.
Centric Compounding LLC’s recall covers products identified with elevated endotoxin levels detected during quality testing. The FDA did not indicate in available materials whether any adverse events or hospitalizations have been reported in connection with the recalled products.
The agency has repeatedly raised concerns about oversight gaps in the compounding pharmacy industry, particularly as IV wellness infusions have moved from traditional medical settings into commercial wellness and spa environments where clinical oversight may be limited.