A widely used hospital drug for treating severe acid reflux is being recalled over concerns that it could trigger dangerous immune reactions.
Fresenius Kabi USA, LLC announced on November 6 that it is voluntarily recalling three lots of its Famotidine Injection, USP, 20 mg per 2 mL, after company testing found what it described as “out-of-specification endotoxin results” in certain reserve samples.
The injectable drug is often used in hospitalized patients with gastroesophageal reflux disease (GERD), ulcers, or other conditions requiring acid suppression when oral medication is not possible.
Elevated endotoxin levels can cause severe systemic responses, including sepsis, septic shock, and potentially death, according to the company’s announcement posted by the U.S. Food and Drug Administration. Fresenius Kabi’s notice stated that non-serious adverse events, such as chills, fever, shivering, and changes in mental status, were reported in connection with one of the lots. However, no adverse events had been reported in the other two.
The recalled lots, numbered 6133156, 6133194, and 6133388, were shipped across the United States between January and May 2025, with expiration dates extending into 2026. The company stated that it initiated its recall at the “user level,” meaning hospitals, pharmacies, and any facility administering the drug are instructed to identify and remove the product immediately.
Famotidine Injection is typically used in hospital settings for short-term treatment of active ulcers and GERD in patients who cannot take oral medication. GERD, which causes persistent acid reflux and heartburn, can lead to inflammation of the esophagus and long-term complications if untreated, according to information from the Mayo Clinic.
Fresenius Kabi’s announcement stated that healthcare facilities should discontinue using the affected lots and return them through the company’s recall process. The notice also encouraged patients who believe they may have received the medication to contact their healthcare provider.
Consumers with questions regarding the recall can call Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, from 8:00 a.m. to 5:00 p.m. Central Standard Time. Potential adverse reactions can also be reported to the company’s medical affairs line or to the FDA’s MedWatch reporting program.
The recall is being conducted with the knowledge of the FDA, as stated in the announcement.