The U.S. Food and Drug Administration (FDA) has acknowledged reports of severe and ongoing contamination involving diethylene glycol (DEG) and ethylene glycol (EG) in children’s cough and cold medicines in India. The agency confirmed that these contaminated products have not been shipped to the United States.
According to the FDA, India’s Central Drugs Standard Control Organisation (CDSCO) has also informed the agency that the affected medicines were not exported from India to any other country. The FDA stated that it remains vigilant to prevent contaminated drugs from entering the U.S. market and has urged manufacturers to ensure that all drugs sold domestically meet the highest quality and safety standards.
India’s CDSCO has identified several cough syrups contaminated with DEG and EG, which have since been recalled in India. These include :
Coldrif, manufactured by Sresan Pharmaceuticals
Re-Life Syrup, manufactured by Shape Pharma Pvt. Ltd.
Respifresh-TR, manufactured by Rednex Pharmaceuticals Pvt. Ltd.
Additionally, a fourth product, Dextromethorphan Hydrobromide Syrup manufactured by Kaysons Pharma Ltd., has been linked to adverse events in children. However, testing in India did not detect DEG or EG contamination. This product too has been recalled as a precautionary measure.
The FDA emphasized that it maintains strict safeguards to prevent unsafe drugs from being imported into the U.S. The agency has contacted drug manufacturers to remind them that all products intended for U.S. sale must comply with current good manufacturing practices and meet proper quality specifications.
In 2023, the FDA issued a guidance document titled Testing of Glycerin for Diethylene Glycol, which alerts manufacturers to the need for rigorous raw material and finished drug testing to ensure product safety. The FDA has also been in coordination with the World Health Organization (WHO) and remains in communication with India’s CDSCO, which has similarly reminded manufacturers about mandatory testing requirements.
Poisoning caused by diethylene glycol or ethylene glycol often begins with symptoms that resemble common illnesses. These include low energy, abdominal pain, vomiting, and diarrhea. As the poisoning progresses, symptoms may worsen to include shortness of breath, rapid breathing, and coma. In severe cases, within days, DEG/EG poisoning can result in kidney failure, liver damage, brain or nervous system injury, and death.
The FDA encourages reporting of such cases through its MedWatch Safety Information and Adverse Event Reporting Program. The agency also reiterated that OTC medications for cough and cold symptoms should not be given to children under 2 years of age, as they can cause serious and potentially life-threatening side effects.
