The U.S. Food and Drug Administration (FDA) is taking proactive steps to protect public health following alarming reports of diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicines produced in India. The agency confirmed that none of the affected products have entered the U.S. market, and India’s Central Drugs Standard Control Organization (CDSCO) has verified that these medicines were not exported to any other country.
In India, several cough syrups found to contain toxic substances were promptly recalled. These include Coldrif by Sresan Pharmaceuticals, Re-Life Syrup by Shape Pharma, and Respifresh-TR by Rednex Pharmaceuticals. A fourth product, Dextromethorphan Hydrobromide Syrup manufactured by Kaysons Pharma Ltd., was also withdrawn from circulation after reports of adverse reactions, though no contamination was detected in testing.
The FDA emphasized that it has robust systems in place to prevent unsafe medicines from reaching U.S. consumers. To reinforce this, the agency contacted drug manufacturers to remind them that all products sold in the U.S. must meet the highest quality standards and comply with current good manufacturing practices (CGMP). The agency also referenced its 2023 guidance, Testing of Glycerin for Diethylene Glycol, which outlines strict testing requirements for raw materials and finished products to ensure drug safety. The FDA continues to work closely with India’s CDSCO and the World Health Organization to stay informed and coordinate efforts to prevent further incidents.
Exposure to DEG or EG can be life-threatening. Early symptoms may appear mild such as fatigue, stomach pain, vomiting, or diarrhea but can quickly worsen to include rapid breathing, confusion, and loss of consciousness. Without urgent treatment, poisoning can lead to kidney failure, liver damage, nervous system injury, or death within days.
The FDA urges consumers to be alert. Anyone who suspects exposure or observes concerning symptoms in a child should seek immediate medical attention and report the incident through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The agency also reminds caregivers that over-the-counter cough and cold medicines should never be used in children under two years old, as they can cause serious and potentially fatal side effects.
Learn more: FDA’s actions to protect children from contaminated cough medicine
