Famotidine Recalled

On Nov. 6, 2025, Fresenius Kabi initiated a voluntary nationwide recall of three lots of famotidine injection, USP, 20mg per 2mL (10mg per mL). The recall was prompted by out-of-specification endotoxin results in certain reserve samples, which can lead to severe systemic reactions such as sepsis and septic shock. Reported non-serious adverse events potentially associated with one lot included chills, fever, shivering, and changes in mental and respiratory status. Famotidine injection is FDA-approved for the short-term treatment of active duodenal ulcer, maintenance therapy for duodenal ulcer patients at reduced dosage after healing, short-term treatment of active benign gastric ulcer, short-term treatment of gastroesophageal reflux disease (GERD) and treatment of pathological hypersecretory conditions. For more information on the recall, see here.