Class I

Drug Recall: 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).

Fresenius Kabi USA, LLC · November 6, 2025

Reason for Recall

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Distribution

Nationwide within the United States as well as AK, HI, and PR.

States Affected

NATIONWIDE

Quantity Affected

2,199,850 vials

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0182-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.