What happened
Greenwich Rx, a 503A compounding pharmacy, announced a voluntary nationwide consumer-level recall of ten lots of compounded glutathione injection 200 mg/mL in 10 mL multidose vials because of potential elevated endotoxin levels. The affected product was intended for subcutaneous injection and was distributed to patients from June 26 through September 21, 2026, with beyond-use dates from October 2 through November 12, 2026. The stated risks include fever, hypotension, inflammatory reactions, anaphylactic shock, and death. The company reported that two patients required emergency department care after intravenous administration of a glutathione product not formulated for IV use. Customers were instructed to stop using recalled product and follow disposal directions. The recall is being conducted with FDA’s knowledge.
Why it matters
From a GMP/manufacturing perspective, potential elevated endotoxin in an injectable compounded product may warrant scrutiny of microbiological controls and the sterility-assurance framework supporting manufacture and release. The consumer-level action also highlights the importance of lot traceability and effective recall communication. The reported use by an unintended intravenous route may matter when assessing product instructions and downstream risk, although the source does not identify a manufacturing root cause.
Key topics: Compounded glutathione injection recall, Potential elevated endotoxin levels, Unintended intravenous administration