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A US Centers for Disease Control and Prevention (CDC)–led investigation identified 12 deaths and other severe adverse events linked to ceftriaxone injections at healthcare facilities in 18 states over 11 months, researchers reported today in Clinical Infectious Diseases.

The investigation, conducted with the Alabama Department of Public Health (ADPH) and other state health departments, began in December 2024 after an Alabama county coroner reported two unexpected deaths immediately following ceftriaxone injection at two separate primary care clinics within a single week. 

ADPH also received reports of a third death in a hospitalized patient, along with two non-fatal adverse events, following ceftriaxone injection.

After an initial investigation found no evidence of tampering, safety breaches, or common lot exposure, CDC and ADPH in February 2025 expanded their investigation, issuing a national call for reports of severe adverse events (SAEs) that involved death or cardiopulmonary resuscitation (CPR) within six hours of receiving an injection of ceftriaxone. 

Reporting health departments submitted data on product exposure, patient medical history, and clinical presentation to the CDC for analysis.

No evidence of tampering, adulteration

From August 2024 to September 2025, 56 SAEs were reported, of which 31 involved death or CPR and were classified as cases. Among the 31 cases (median age, 67 years), 12 patients died, 19 had CPR successfully administered, 23 had anaphylaxis-type reactions, 21 had previous ceftriaxone exposure, and 24 had cardiac comorbidities. 

Respiratory infection was the most common indication (42%) for ceftriaxone use among case-patients. Beta-blockers were the most common medication used (61%).

Product testing showed no evidence of tampering, adulteration, endotoxin, or purity/potency issues. Evaluation of Medicare claims and the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance System found that national adverse event trends were stable from 2016 through 2019 and 2020 through 2024.

“The absence of a common source etiology, epidemic peak, explanatory product quality issue, or substantial change in national adverse event occurrence over time suggests that the three initial deaths reported in December 2024 may represent a chance clustering of known, albeit severe, adverse reactions to ceftriaxone,” the study authors wrote, adding that the investigation highlights the need for ongoing vigilance for ceftriaxone SAEs.