Fresenius Kabi USA has initiated a voluntary nationwide recall of three lots of famotidine injection, USP 20 mg/2 mL (10 mg/mL, 2 mL vial), according to a company announcement posted on the FDA website.
The recall affects the following lot numbers 6133156 and 6133194, with expiration dates of August 2026, and lot number 6133388, with an expiration date of October 2026.
The recall stems from “out-of-specification endotoxin results in certain reserve samples of one lot,” the company said. The two additional lots are being recalled as a precaution.
Elevated endotoxin levels may lead to severe systemic reactions, including sepsis, septic shock, inflammatory and life-threatening immune responses, and potentially death.
Nonserious adverse events have been reported in association with lot 6133156, including chills, altered mental status, changes in respiratory status, fever/increased body temperature, shivering, and shaking.
Famotidine injection is indicated in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers or as an alternative to the oral dosage forms for short-term use in patients unable to take oral medication for certain conditions, including active duodenal ulcer, benign gastric ulcer or gastroesophageal reflux disease, or maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Clinicians should be alert for symptoms potentially related to endotoxin exposure in patients who have received the affected product; document use of the product in affected lots (if already administered) and monitor patients carefully; and inform prescribing clinicians and nursing staff so they can monitor for signs of endotoxin-related reaction.
Patients should be advised to contact their physician or healthcare provider if they experienced any problems that may be related to receiving the affected drug.
Clinicians should check their inventory for famotidine injection USP 20 mg/2 mL vials; discontinue use, dispensing, and distribution of affected lots; and segregate and quarantine any affected units to prevent inadvertent use.
For questions or product return coordination, contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459 or email at productcomplaint.USA@fresenius-kabi.com.
Adverse events or quality issues related to this recall should be reported to Fresenius Kabi (1-800-551-7176) and to the FDA MedWatch program.