Alert Overview

This alert from the World Health Organization (WHO) concerns three contaminated oral liquid medications identified in India and reported to the WHO on 8 October 2025.

The impacted products are liquid medications that include active substances typically used to ease cold, flu, and cough symptoms.

On that same day, India’s Central Drugs Standard Control Organization (CDSCO) notified WHO of the presence of Diethylene Glycol (DEG), a toxic chemical, in at least three of these medications. This came in response to WHO findings from 30 September 2025, which pointed to local outbreaks of sudden illness and deaths among children in India. CDSCO communicated that the children reportedly ingested these contaminated medicines.

The tainted products were identified as specific batches of COLDRIF, Respifresh TR, and ReLife—manufactured respectively by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma.

Following this discovery, CDSCO confirmed that state authorities have ordered an immediate suspension of manufacturing at the implicated facilities and have revoked product licenses. Furthermore, a recall of the contaminated medicines is underway, carried out by governing state bodies.

According to CDSCO’s report to WHO, none of these batches have been exported outside India so far, and there’s no indication of illegal distribution abroad. Nonetheless, WHO advises national regulators to conduct focused monitoring of local markets, especially informal and less-regulated supply chains where these kinds of products might circulate without detection. Authorities should also examine the potential risks of other oral liquid products that may share manufacturing origins, particularly those made after December 2024.

WHO continues to work in close coordination with Indian health agencies to trace the contamination source and take measures to protect public health.

The medicines highlighted in this alert are classified as substandard because they do not comply with quality requirements and official specifications.

Identifying Contaminated Products

Please refer to the annex below for specific information about the batch numbers affected.

Health Risks

These compromised medicinal products pose a grave threat to consumers and may result in serious, potentially fatal conditions. Diethylene Glycol is highly poisonous when ingested, and its consumption can lead to death. The contaminated oral liquids listed in this alert are especially hazardous for children and can cause severe harm or loss of life. Symptoms of poisoning may include stomach pain, nausea, vomiting, diarrhea, urinary difficulties, confusion, and acute kidney damage which can be fatal.

To safeguard public health, urgent actions must be taken to identify and remove these dangerous products from the market.

Guidance for Health Professionals, Regulatory Bodies, and the Public

Medical personnel are urged to promptly report any detection of these defective products or any associated side effects—or ineffectiveness—to their local health authorities or national drug safety centers. WHO encourages more thorough inspections and cautious management of medicines, particularly in nations and areas that could be affected. Monitoring should be especially vigilant within unregulated or informal markets.

National health regulators and law enforcement agencies should notify WHO immediately if any of these medications show up in their regions.

If you are in possession of any of these contaminated products, WHO advises that you refrain from using them. In case you or someone you know has used these products or experienced unexpected effects, seek urgent care from a healthcare provider or contact your nearest poison control center.

Annex: Medications listed in WHO Medical Product Alert No. 5/2025