Cough syrup tragedies: Global incidents, causes, and regulatory lessons

Abstract

Cough syrups are among the most widely used pediatric medications worldwide. However, recurring mass- poisoning events due to contamination with diethylene glycol or ethylene glycol have caused numerous child deaths over nearly a century. From the 1937 Elixir Sulfanilamide tragedy in the United States to the recent Coldrif incident in India (2025), these disasters highlight failures in manufacturing, excipient sourcing, and regulatory vigilance. This review summarizes the chemical and toxicological basis of glycol poisoning, presents a chronological analysis of major global incidents, and examines regulatory reforms enacted to prevent recurrence. It emphasizes the necessity of rigorous testing of raw materials and finished oral liquids, international harmonization of quality standards, and transparent pharmacovigilance to protect vulnerable populations.