FDA Confirms Contaminated Syrups Not Exported to U.S.; India Recalls Products

The U.S. Food and Drug Administration (FDA) confirmed it is aware of ongoing and severe contamination involving diethylene glycol (DEG) and ethylene glycol (EG) in certain children’s cough and cold medicines in India.¹ The agency stated that these contaminated products have not been shipped to the United States.²

India’s Central Drugs Standard Control Organisation (CDSCO) also informed the FDA that the affected medicines were not exported from India to any other country.³

Contaminated Products and Recalls in India

The CDSCO has identified and recalled several cough syrups contaminated with DEG and EG, which are industrial solvents toxic to humans.⁴

FDA and CDSCO Safety Measures

Both the FDA and CDSCO have taken steps to address the contamination issue and prevent future occurrences:

• FDA Actions:
  • Maintains strict safeguards to prevent unsafe drugs from being imported into the U.S.⁵
  • Contacted drug manufacturers to reinforce the need to comply with Current Good Manufacturing Practices (cGMP) and meet proper quality specifications.⁶
  • Issued 2023 guidance, Testing of Glycerin for Diethylene Glycol, to alert the industry to the need for rigorous raw material and finished drug testing.⁷
  • Coordinating with the World Health Organization (WHO) and communicating with the CDSCO.⁸
• CDSCO Actions (Post-Incident): Following the contamination cases, the CDSCO and various state authorities have significantly tightened domestic regulations, including:
  • Ordering an immediate halt to production at the implicated manufacturing sites and suspending product authorizations.⁹
  • Mandating that manufacturers test all raw materials (like glycerin, propylene glycol, and sorbitol) for DEG and EG prior to use, with a permissible limit not exceeding 0.10%.¹⁰
  • Issuing directives for rigorous batch testing of finished oral liquid products for DEG/EG.¹¹

Risk of DEG/EG Poisoning

Diethylene glycol and ethylene glycol poisoning can be severe and life-threatening, especially in children.¹²

• Early Symptoms: Low energy, abdominal pain, vomiting, and diarrhea.¹³
• Progressed Symptoms: Shortness of breath, rapid breathing, and coma.¹⁴
• Severe Complications: Within days, poisoning can cause kidney failure, liver damage, brain or nervous system injury, and death.¹⁵

The FDA advises against giving over-the-counter medications for cough and cold symptoms to children under 2 years of age due to the potential for serious side effects, and encourages reporting of adverse events through its MedWatch Safety Information and Adverse Event Reporting Program.

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