All PlansCoverageHigh impact
Voluntary nationwide recall: Famotidine (Fresenius – November)
UPMC Health Plan·Pharmacy, Critical Care, Emergency Medicine·Pharmacy
Effective date
Nov 7, 2025
We identified it
Aug 7, 2026
Summary
Fresenius Kabi is recalling three lots of Famotidine Injection 20 mg/2 mL due to elevated endotoxin levels that may cause serious adverse reactions including sepsis, septic shock, or death. Billing teams must identify patients who received the affected lots and coordinate with clinical staff to notify them and discontinue use immediately.
Action Required
Immediately: Clinical and billing teams must identify all patients who received Famotidine Injection from recalled lots 6133156, 6133194, or 6133388. Contact prescribing providers and patients to discontinue use and report any adverse events. Verify lot numbers in billing records and pharmacy systems. Coordinate with pharmacy to quarantine remaining inventory from these lots. Document all communications and adverse event reports. Contact Fresenius Kabi Quality Assurance at 866-716-2459 (TTY: 711, Monday-Friday 8 a.m.-5 p.m. CST) or visit FDA website for additional guidance. Review claims for patients who received affected lots and prepare for potential liability adjustments. Flag any claims submitted for services related to adverse reactions from these lots for separate handling.