Fresenius Kabi USA, LLC recalls 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
Recalled December 3, 2025 · FDA recall D-0182-2026 · Fresenius Kabi USA
Hazard
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. · FDA Class I
Units
2,199,850 vials
Sold at
Nationwide within the United States as well as AK, HI, and PR.
Description
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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).
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →