Compounded Glutathione Injection recalled over elevated endotoxin levels
Greenwich Rx issued a voluntary nationwide recall of compounded Glutathione Injection due to potential elevated endotoxin levels. Endotoxin contamination can cause fever, chills, low blood pressure, and septic shock in patients receiving injections. Affected lots should not be administered; pharmacies are asked to quarantine and return stock.
On 1 October 2026 Greenwich Rx initiated a voluntary nationwide recall of compounded Glutathione Injection due to potential elevated endotoxin levels. The official FDA recall notice ↗ identifies specific lot numbers; affected product should not be administered and must be quarantined and returned.
Why endotoxin contamination is serious
Bacterial endotoxins (lipopolysaccharides) ↗ are components of gram-negative bacterial cell walls. When introduced intravenously, even tiny amounts can trigger a systemic inflammatory response — causing fever, rigors, hypotension, and in severe cases septic shock ↗. Endotoxin contamination of injectable products is one of the most serious compounding quality failures. The FDA's cGMP regulations ↗ require rigorous endotoxin testing before release of sterile injectables.
What pharmacies and patients should do
Healthcare facilities and pharmacies should immediately quarantine all affected lots, stop dispensing, and contact Greenwich Rx for return authorisation. Patients who have received the product and experience fever, chills, or low blood pressure should seek immediate medical care. Adverse events should be reported to FDA MedWatch ↗. For recall classifications see the FDA Recall Classification guide ↗.
FAQ
How do I know if my batch is affected by this recall?
Check the lot number printed on the product label or carton against the specific lots listed in the official FDA recall notice ↗. If your lot number matches, do not use the product and contact your pharmacy or the recalling firm. You can also search the FDA Recalls database ↗ for the latest status.
What recall class is this?
FDA assigns recall classes: Class I (most serious — reasonable probability of serious adverse health consequences or death), Class II (may cause temporary or medically reversible adverse health consequences), or Class III (unlikely to cause adverse health consequences). The class is listed in the official notice ↗. For definitions see the FDA recall classification guide ↗.