Fresenius Kabi Famotidine Injection Recall (2025): Elevated Endotoxin Risk in Three Lots
Urgent safety alert: Fresenius Kabi has issued a voluntary nationwide recall of three lots of Famotidine Injection, USP 20 mg per 2 mL. Routine reserve testing revealed endotoxin levels above U.S. Pharmacopeia (USP) limits. Health-care facilities, distributors, and wholesalers should immediately stop using the affected vials, quarantine inventory, and arrange product returns.
Recall Overview & Timeline
- Recall initiated: November 6, 2025 • FDA notice: November 7, 2025
- Product strength & format: Famotidine Injection, USP 20 mg/2 mL (10 mg/mL) single-dose vials
- Manufacturer/labeler: Fresenius Kabi USA, LLC
- Hazard: Out-of-specification endotoxin results that can lead to fever, chills, sepsis, or septic shock
- Distribution: United States (shipped January – May 2025)
Sources
Affected Fresenius Kabi Lots & NDCs
| Lot | Expiration | Unit-of-Use NDC | Unit-of-Sale NDC | First Ship | Last Ship |
|---|---|---|---|---|---|
| 6133156 | 08/2026 | 63323-739-11 | 63323-739-12 | 01/02/2025 | 02/11/2025 |
| 6133194 | 08/2026 | 63323-739-11 | 63323-739-12 | 02/04/2025 | 04/11/2025 |
| 6133388 | 10/2026 | 63323-739-11 | 63323-739-12 | 05/23/2025 | 05/23/2025 |
Endotoxin Hazard Explained
Testing of reserve samples from lot 6133156 detected endotoxin levels above the USP limit. Because the three lots were manufactured in close succession, Fresenius Kabi expanded the recall to lots 6133194 and 6133388 as a safety precaution.
Endotoxins are lipopolysaccharide fragments of gram-negative bacterial cell walls. When injected they may cause:
- Chills, shivering, or rigors
- High fever
- Respiratory or mental-status changes
- Sepsis or septic shock, which can be life-threatening
Required Actions for Health-Care Providers
- Quarantine and discontinue distribution, dispensing, and use of the recalled lots.
- Arrange product returns with Fresenius Kabi (see contact details below).
- Notify any downstream customers or clinics that may have received the product.
- Report adverse events to Fresenius Kabi and/or FDA MedWatch.
Return & Adverse-Event Contacts
Product returns / quality questions
Fresenius Kabi USA Quality Assurance: 1-866-716-2459 (Mon–Fri, 8 a.m.–5 p.m. CST) • productcomplaint.USA@fresenius-kabi.com
Adverse-event or medical inquiries
Fresenius Kabi Medical Affairs/Vigilance: 1-800-551-7176 • adverse.events.USA@fresenius-kabi.com
FDA MedWatch online: www.fda.gov/medwatch/report.htm
Official Recall Images
Frequently Asked Questions
Which lots of Fresenius Kabi Famotidine Injection are included in the recall?
Lots 6133156, 6133194, and 6133388, all with expiration dates of 08/2026 or 10/2026, are subject to the recall.
Why did Fresenius Kabi recall these Famotidine Injection vials?
Reserve samples exceeded USP endotoxin limits, indicating a risk for serious systemic reactions such as fever or septic shock.
How should facilities handle recalled Fresenius Kabi Famotidine Injection stock?
Immediately quarantine the vials, cease distribution or use, notify downstream customers, and follow the return instructions provided by Fresenius Kabi.
What symptoms may follow administration of recalled Fresenius Kabi Famotidine Injection?
Patients should seek urgent care for fever, chills, rapid breathing, confusion, or other signs of infection or sepsis.
How do I obtain credit for returned Fresenius Kabi Famotidine Injection product?
Contact Fresenius Kabi Quality Assurance at 1-866-716-2459 to arrange return authorization and reimbursement.
How can I report an adverse event linked to Fresenius Kabi Famotidine Injection to the FDA?
Submit a report online through FDA MedWatch (link) or call 1-800-332-1088 to request a reporting form.