Critical Alert
Fresenius Kabi USA Recalls Famotidine Injection
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0182-2026Drug / Pharmaceutical
Fresenius Kabi USA Recalls Famotidine Injection
Fresenius Kabi USA, LLC · Class I — Most Serious
Product Description
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 for Recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database