Recalling firm
Fresenius Kabi USA, LLC
Product type
Drug
Status
Ongoing
Report date
2025-12-03
Distribution
Nationwide within the United States as well as AK, HI, and PR.
Firm state
IL
Product quantity
2,199,850 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
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).
Code / lot info
Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.