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Centric Compounding Recalls Injectables After Supplier API Tests Show High Endotoxin Levels

The voluntary recall points to a direct patient-safety risk from endotoxin-contaminated ingredients used in widely distributed compounded wellness injections.

Overview

  • The company voluntarily recalled six lots of Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost following an FDA recall notice that flagged elevated bacterial endotoxin levels in the glutathione active pharmaceutical ingredient.
  • The FDA posted the recall on Sept. 13 and the affected 30 mL multidose vials were distributed nationwide by home delivery and to prescribers.
  • Centric Compounding reported nine consumer adverse-event reports that include fever, chills, chest pain, nausea, vomiting, headache and malaise, and the FDA warned injected endotoxins can cause fever, low blood pressure, severe inflammatory reactions, anaphylaxis and death.
  • Customers and distributors are being notified by email, replacements are being arranged, and consumers are urged to stop using and discard the recalled lot numbers with beyond-use dates from August through September 2026.
  • The incident underscores regulatory gaps: compounded formulations are not reviewed for safety and effectiveness like mass-produced drugs, a fact tied to repeated contamination events and growing scrutiny of the compounding sector.