FDA Reports Adverse Reactions to Medisca Intravenous Glutathione
At least 30 patients have reported adverse reactions to a Medisca intravenous glutathione product with elevated endotoxin levels, according to the FDA.
3 reports on this incident · first at Aug 28, 2026, 7:46 a.m. ET
Earlier reports
Aug 28, 2026, 7:52 a.m. ET
FDA Closes Recall of Medisca Intravenous Glutathione Over Endotoxin Levels
The U.S. Food and Drug Administration has closed its recall action involving Medisca Inc.'s intravenous glutathione, according to a report from Medical Daily. The agency considers the recall carried out, the report said.
The recall, initiated August 20, 2026, covers the product with identifying code 229536, which was distributed in the United States. The FDA warned of elevated endotoxin levels in the injections, which can cause fever, chills, pain, dizziness, signs of shock, and sepsis-like symptoms. At least 30 patients had adverse reactions, Medical Daily reported.
Anyone who still has the product should contact the clinician who administered it and mention the product and timing, the report said. The status of the recall is ongoing, according to Medical Daily.
Aug 28, 2026, 7:46 a.m. ETFirst report
FDA Warns of Elevated Endotoxin Levels in Medisca Intravenous Glutathione
The U.S. Food and Drug Administration (FDA) has issued an alert regarding a specific lot of intravenous glutathione manufactured by Medisca Inc., according to a report from Medical Daily. The alert, initiated on August 20, 2026, and reported on August 27, 2026, cites elevated endotoxin levels in the injections as the reason for the warning.
The affected product is identified by lot code 229536. The FDA advises that patients who received the product should contact the clinician who administered it and mention the product and timing. The agency reports that at least 30 patients have experienced adverse reactions, including fever, chills, pain, dizziness, signs of shock, and sepsis-like symptoms. The status of the alert is ongoing, and the investigation is developing.
Was this report accurate and useful?
Sources
Revision history
- Version 128 Aug 2026, 11:46current
First published.
- Version 128 Aug 2026, 12:22current
First published.
- Version 128 Aug 2026, 11:52current
First published.
How we work
This site models an investigative reporter rather than a wire desk. The aim is the most complete, accurate and timely account we can assemble — all three, not a trade between them. Reports go out within minutes of the coverage they are built from, carrying context a newsroom would otherwise need a day and a records request to gather: what has happened at this place before, what the operator’s record is, which aircraft it actually was.
Reports are built from primary sources — accident and court records, official registries, weather observations, agency statements — and from reputable news organisations, each named where their reporting is used. Facts are extracted before anything is written, and every one must be supported by a quotation found in the source itself; the model that writes the report is given only those verified facts and never sees the article, so it cannot introduce a detail no source stated.
Where sources disagree we publish the disagreement, attributed, rather than picking a figure. Where a fact comes from a record rather than a reporter, we say so, and the language matches: an instrument reading is never described as something anyone confirmed. Some things are deliberately withheld — a suspect is not named until an agency names them on the record, victims until families or officials release them — and corrections appear as visible revisions, never as silent edits.
None of that makes a report true. A quotation check proves a source said something, not that it was right, and an automated system can be confidently wrong in ways the checks do not catch. If something here is wrong, the feedback above is how it gets found. The full methodology, including what we refuse to publish.