Fresenius Kabi Issues Voluntary U.S. Recall of Three Lots of Famotidine Injection Due to Endotoxin Concerns

Fresenius Kabi Issues Voluntary U.S. Recall of Three Lots of Famotidine Injection Due to Endotoxin Concerns

By, Admin 14 November 2025

Fresenius Kabi, a global healthcare company specializing in infusion, transfusion, and clinical nutrition therapies, has initiated a voluntary recall of three lots of Famotidine Injection, USP (20 mg/2 mL) in the United States. The affected lot numbers are 6133156, 6133194, and 6133388. The recall is being conducted to the user level.

Reason for the Recall

The recall was prompted by out-of-specification endotoxin results detected in reserve samples from one lot. Following the investigation, Fresenius Kabi included two additional lots as a precautionary measure.

Elevated endotoxin levels can cause severe systemic reactions, including:

  • Sepsis
  • Septic shock
  • Strong inflammatory responses
  • Potentially life-threatening immune reactions

One lot has been linked to non-serious adverse events, such as chills, fever, shivering, altered mental status, and respiratory changes. No adverse events have been reported for the remaining two lots.

Product Use

Famotidine Injection is typically used in hospitalized patients when oral administration is not possible, including:

  • Short-term treatment of active duodenal ulcers
  • Maintenance therapy following duodenal ulcer healing
  • Short-term treatment of benign gastric ulcers
  • Short-term treatment of GERD
  • Treatment of pathological hypersecretory conditions

Instructions for Healthcare Providers

Fresenius Kabi has notified distributors and customers and initiated product returns.
Healthcare facilities are advised to:

  • Stop distribution and use immediately
  • Quarantine the affected lots
  • Return all impacted units to Fresenius Kabi
    Distributors must promptly notify all customers who may have received the recalled product.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!