Fresenius Kabi USA, LLC recalls Famotidine Injection
- Recalling company
- Fresenius Kabi USA, LLC
- Product
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
- Reason
- Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Nov 6, 2025
- Reported
- Dec 3, 2025
- Distribution
- Nationwide within the United States as well as AK, HI, and PR.
- Status
- Ongoing
- Quantity
- 2,199,850 vials
- Lot / codes
- Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- Company location
- Lake Zurich, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0182-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0182-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.