Six lots of injectable products from Centric Compounding are under recall after the company received reports of reactions and identified elevated endotoxin levels in a glutathione ingredient. The products are Glutathione 200 mg/mL, Myer's Cocktail and Tri-Immune Boost. The FDA-distributed recall notice, circulated September 14, says nine adverse events had been reported in connection with the affected products.
The recall was initiated September 9. That is the date of the company's action, not the publication date of this article. Clinics that obtained the injections, and patients who may have received them, need to check the lot details in the FDA notice rather than assume that every product with the same name is affected.
Endotoxins are components of certain bacteria. Their presence in an injectable is a different problem from whether the advertised active ingredient is present at the stated strength. A vial can contain the expected compound and still be unsafe to inject. The recall notice warns that endotoxin exposure can cause fever, chills and other acute reactions, with potentially severe outcomes. It reports adverse events; it does not establish that every reported symptom was caused by the recalled products.
What the recall does and does not show
The FDA notice identifies an elevated-endotoxin finding in the glutathione active pharmaceutical ingredient used for the affected preparations. It does not establish that all compounded injectables, or peptide products as a class, have the same defect. None of the three recalled products is identified in the notice as a peptide treatment. That distinction matters: this is a sterile-compounding and ingredient-control story, not evidence of a peptide-specific contamination rate.
There is, however, a practical lesson for anyone evaluating an injectable supply chain. A certificate stating a compound's identity or purity cannot replace testing and controls directed at contamination, including endotoxins. Our guide to checking research-peptide quality explains why those measurements answer different questions. For compounded medicines, the distinction between 503A pharmacies and 503B outsourcing facilities also matters when interpreting the applicable manufacturing and oversight requirements.
The agency had already warned compounders in August against using dietary-supplement-grade glutathione for injectable products. That earlier FDA alert described a broader set of patient reactions associated with glutathione injections; it should not be conflated with the nine reports cited in Centric's recall. Our earlier report on glutathione IV reactions covers that separate warning.
Anyone holding an affected lot should follow the recall instructions in the FDA notice and contact their prescriber or pharmacist. A person who develops symptoms after an injection should seek medical advice promptly. The immediate question for facilities is narrower than a general debate over compounded medicine: whether the exact lot they used is on the recall list, and whether recipients have been notified.
