On November 6, 2025, Fresenius Kabi announced a voluntary nationwide recall of three lots of Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vial. Healthcare providers, distributors, and other stakeholders involved in the use or distribution of this product should assess their inventory immediately to prevent potential risks to patients.
What Changed?
Fresenius Kabi, a global healthcare company and leading provider of essential medications, issued the recall for three specific lots of Famotidine Injection. This proactive action follows findings of out-of-specification endotoxin results during reserve sample testing for one lot, prompting the inclusion of two other lots as a precautionary measure. Elevated endotoxin levels in injectable medications can lead to severe systemic reactions, including sepsis, septic shock, and life-threatening immune responses.
Clinical Risks Associated with Elevated Endotoxin Levels
The potential adverse effects of increased endotoxin in Famotidine Injection include symptoms such as chills, fever, respiratory or mental status changes, shivering, and shaking. These reactions have been reported for one of the recalled lots, but no adverse events have been linked to the other two. While some adverse outcomes were considered non-serious, high endotoxin levels can escalate to critical health emergencies, making immediate action essential.
Affected Lot Details
The following lots are part of the recall:
- Lot number 6133156 – Expiration date: January 2, 2025 – First ship date: February 4, 2025 – Last ship date: May 23, 2025
- Lot number 6133194
- Lot number 6133388
Healthcare facilities and distributors must immediately discontinue use or distribution of these lots and arrange for their return to Fresenius Kabi.
Recommended Actions for Stakeholders
For Distributors
Distributors are instructed to notify customers who may have received these affected lots. All units must be returned promptly.
For Healthcare Providers
Healthcare facilities should discontinue the use, distribution, and dispensing of the recalled Famotidine Injection immediately. Patients experiencing any adverse effects related to the use of these lots should consult with their healthcare provider.
For Consumers
Patients who have concerns about potential exposure or adverse reactions should contact their physician. Additionally, any adverse reactions or quality concerns can be reported directly to Fresenius Kabi or the FDA’s MedWatch Adverse Event Reporting Program.
Regulatory Context
This recall is conducted with the awareness of the U.S. Food and Drug Administration (FDA). Famotidine Injection is commonly used for conditions such as gastroesophageal reflux disease (GERD), duodenal ulcers, and pathological hypersecretory conditions when oral replication is not feasible. Ensuring product safety and performance during distribution and use is fundamental to maintaining regulatory compliance and protecting patient health.
Conclusion
The recall of Famotidine Injection underscores the importance of rigorous testing and quality assurance in healthcare manufacturing. Stakeholders are urged to follow recall instructions promptly to minimize risks and safeguard patient outcomes. For specific details regarding the recall process, contact Fresenius Kabi directly or report adverse events to the FDA.
Disclaimer
This article is intended for informational purposes only. It is not legal or clinical advice. Please consult regulatory guidance or professional counsel for detailed recommendations.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10