# Major Recall Alert: Famotidine Injection, USP 20 mg per 2 mL Recalled Due to Out-of-Specification Endotoxin Results
Fresenius Kabi has issued a nationwide recall of three lots of **Famotidine Injection, USP 20 mg per 2 mL (10 mg per mL)**. The recall is due to **out-of-specification (OOS) endotoxin results**, which have been identified in reserve samples from one lot. As a safety precaution, two additional lots are also included in this recall. Here’s what you need to know about the recall, its potential health risks, and how to take immediate action.
## Why This Recall is Important
### Elevated Health Risks
Endotoxins are toxic substances that can cause severe health complications when present in higher-than-acceptable levels. These complications can include:
- **Sepsis**
- **Septic shock**
- **Inflammatory responses**
- **Life-threatening immune reactions**
Although non-serious adverse events, such as chills, fever, changes in mental or respiratory status, and shivering, have only been reported in relation to one lot, the **potential for severe health consequences underscores the urgent need for this recall**.
Famotidine Injection, USP, is commonly used in hospitalized patients who require short-term treatment for pathological hypersecretory conditions, intractable ulcers, or as an oral alternative in certain cases. Given its critical use, healthcare providers must take immediate action to avoid potential harm.
## Details of the Recall
Fresenius Kabi, a leading provider of essential medical products, voluntarily issued the recall on **November 6, 2025**, notifying distributors and healthcare facilities across the United States.
### Key Recall Information:
- **Product Name:** Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), packaged in a 2 mL vial
- **Affected Lot Numbers:** 6133156, 6133194, 6133388
- **Reason for Recall:** Out-of-specification endotoxin results in reserve samples from one lot, with two additional lots included as a precaution
Currently, no adverse events have been reported for the second or third lots, but all three are being recalled to guarantee patient safety.
For an official source and additional recall details, visit the [FDA Recall Notification](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).
## What You Should Do
If your healthcare facility or medical practice has any of the affected lots, follow these immediate steps:
- **Discontinue Use:** Stop distributing, dispensing, or administering the product.
- **Return the Product:** Contact Fresenius Kabi for instructions on returning the recalled lots.
- **Notify Affected Patients:** If necessary, alert patients who may have been exposed to these products.
### Contact Information:
- Fresenius Kabi USA Quality Assurance: **1-866-716-2459** (Monday–Friday, 8:00 a.m.–5:00 p.m. CST)
- Report adverse reactions to Fresenius Kabi Medical Affairs/Vigilance: **1-800-551-7176** or email:
- **productcomplaint.USA@fresenius-kabi.com**
- **adverse.events.USA@fresenius-kabi.com**
Additionally, adverse reactions or quality issues can also be reported to the FDA through the MedWatch Adverse Event Reporting Program, accessible online, by mail, or through fax.
## Stay Safe – Get Instant Recall Alerts
Medical product recalls can happen suddenly, and staying informed is crucial for both healthcare providers and consumers. The **out-of-specification endotoxin results** in this famotidine injection prompt critical action to protect patients. Ensure your facility takes the appropriate measures to return affected products and report any adverse events promptly.
To stay updated on the latest recalls and safety alerts, **download the MyRecalls app today!** With real-time alerts, you can easily track product recalls, ensuring timely and effective safety measures.
Stay informed, stay safe, and help spread the word about this important medical product recall.