FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. The agency has confirmed these products have not been shipped to the U.S.
Additionally, the Indian health authority – the Central Drugs Standard Control Organisation –informed FDA these products were not exported from India to any other country.
The agency remains vigilant to prevent contaminated drugs from entering the U.S. and asks manufacturers also to remain vigilant to ensure drugs that are marketed in the U.S. remain of highest quality and are safe.
Contaminated products and other concerns
FDA is aware of the following cough syrups in India contaminated with DEG/EG as identified by India’s Central Drugs Standard Control Organisation. These products have been recalled in India:
- Coldrif, manufactured by Sresan Pharmaceuticals
- Re-Life Syrup, manufactured by Shape Pharma Pvt. Ltd.
- Respifresh-TR, manufactured by Rednex Pharmaceuticals Pvt. Ltd.
According to news reports, there is a fourth cough medicine that is linked to adverse events in children in India. However, India’s testing has not found DEG/EG contamination. This product also was recalled.
- Dextromethorphan Hydrobromide Syrup, manufactured by Kaysons Pharma Ltd.
FDA actions
- The agency has strict safeguards to prevent unsafe drugs from being imported into the U.S.
- FDA contacted drug manufacturers to remind them that products intended for sale within the U.S. must meet current good manufacturing practice requirements and appropriate quality specifications. In 2023, the agency issued a guidance document, Testing of Glycerin for Diethylene Glycol, to alert the industry of the required raw material and finished drug testing to ensure drugs are safe for use.
- The agency has been in contact with India’s Central Drugs Standard Control OrganisationExternal Link Disclaimer, which also sent manufacturers a reminder of the requirements for testing.
- FDA also is coordinating with the World Health Organization to stay informed on this investigation.
DEG/EG poisoning symptoms
DEG/EG poisoning usually starts with symptoms similar to early stages of sickness for many illnesses such as low energy, abdominal pain, vomiting and diarrhea. As symptoms progress, patients experience shortness of breath, rapid breathing and may fall into a coma. Within days, severe DEG/EG poisoning can lead to kidney failure, liver damage, brain or nervous system injury and death.
Information for consumers
- If you or your child have symptoms that may be related to DEG/EG poisoning, contact your health care professional immediately, and tell them about any recent use of OTC products – particularly imported products.
- Report these issues to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
- FDA does not recommend over-the-counter medications for cough and cold symptoms in children younger than 2 because they can cause serious and potentially life-threatening side effects.
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