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# Fresenius Recalls 4 Lots of Famotidine Injection
- URL: https://www.fdaweb.com/fresenius-recalls-4-lots-of-famotidine-injection/
- Published: 2025-11-10T12:00:00.000Z
- Updated: 2026-09-14T15:26:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160190

Fresenius Kabi has recalled (Class 1) three lots of its famotidine injection after reserve samples from one lot tested out of specification for endotoxin levels. According to the company, elevated endotoxin levels in injectable drugs can trigger serious systemic reactions, including sepsis, septic shock, and life-threatening inflammatory responses. One of the implicated lots has been associated with several non-serious adverse events, including chills, fever, shivering, altered mental status, and respiratory changes, the company says. No adverse events have been reported for the other two lots.

Famotidine injection is used in hospitalized patients for short-term treatment of duodenal and gastric ulcers, GERD, and pathological hypersecretory conditions, or when oral administration is not possible. Healthcare providers are advised to stop using the recalled lots immediately, a recall notice says. Fresenius Kabi says it is notifying distributors and customers and arranging for the return of affected vials.