In October 2025, India witnessed yet another devastating outbreak of diethylene glycol (DEG) poisoning, claiming young lives and highlighting a persistent global crisis. DEG is a clear, colorless, practically odorless, viscous liquid with a deceptively sweetish taste¹ that has caused over 300 child deaths globally between 2022-2023 alone².
Nevethaa Nataraj, Pharm D has also started a discussion in MedBound Hub stating that:
“A batch of cough syrup gets distributed. Labels look fine. Dosage seems standard. But inside? A toxic industrial solvent,” Nevethaa Nataraj, Pharm D
This toxic chemical, when illegally substituted in medications, transforms life-saving drugs into deadly poisons. From the 1937 United States tragedy that killed 107 people to the ongoing 2025 India outbreak, understanding DEG's dangers remains critical for healthcare professionals, parents, and public health officials worldwide.
Diethylene glycol is a clear, colorless, practically odorless, viscous, hygroscopic liquid with a sweetish taste¹.
These seemingly innocuous physical properties make DEG particularly dangerous. Moreover, its sweet taste and similarity to safe pharmaceutical excipients like glycerin allow it to be substituted without immediate detection. This industrial chemical has no legitimate place in pharmaceutical or food products, yet its low cost and physical resemblance to approved ingredients make it an attractive, albeit deadly, adulterant for unscrupulous manufacturers. DEG should never be confused with propylene glycol, a structurally different and FDA-approved safe alternative commonly used in pharmaceuticals and food products.
Historically, DEG was used as a solvent in medications, most infamously in the 1937 Elixir Sulfanilamide disaster that resulted in 107 deaths, many of them children². This tragedy led to the enactment of the Federal Food, Drug, and Cosmetic Act, which mandated safety testing before drug marketing². Today, DEG is NOT approved for pharmaceutical or food use in any country with proper regulatory oversight.
Despite regulations, DEG continues to appear in medications through illegal substitution. Small manufacturers maximize profits by replacing expensive pharmaceutical-grade glycerin and propylene glycol with cheaper DEG³. Research has revealed that paracetamol (acetaminophen), propylene glycol, and glycerin are the primary targets for DEG adulteration during pharmaceutical processing³. The financial incentive is substantial DEG costs significantly less than approved excipients, and negligent manufacturers prioritize profit over patient safety³.
Counterfeit and substandard drugs frequently contain DEG as a diluent instead of proper active compounds³, creating a hidden threat in global pharmaceutical supply chains.
Yes, diethylene glycol is highly toxic to humans when consumed and can prove fatal⁴. The severity of DEG poisoning cannot be overstated, with documented mortality rates exceeding 70% in affected children³.
The historical record paints a devastating picture. In 1937, the United States experienced 107 deaths from DEG-contaminated medication². Between 1995-1996, Haiti saw at least 80 child fatalities from DEG-contaminated glycerin in acetaminophen syrup². From 1990-1998, similar incidents in Argentina, Bangladesh, India, and Nigeria resulted in hundreds of children's deaths². The 2006 Panama outbreak caused multiple fatalities², and most alarmingly, between 2022-2023, contamination incidents spanning at least seven countries were associated with more than 300 deaths predominantly in children under age five². As recently as October 2025, India reported localized clusters of acute illness and child fatalities linked to DEG-contaminated medicines⁴,⁵.
Children are disproportionately vulnerable because DEG most commonly contaminates pediatric formulations, particularly paracetamol (acetaminophen) syrups cough and cold medications⁴,⁵, and antiemetic preparations². Parents administering what they believe to be safe, routine medications to their sick children unknowingly expose them to a potentially lethal toxin.
DEG poisoning progresses through three distinct clinical stages, each more severe than the last¹.
Stage 1 – Initial Presentation: The first phase consists of gastrointestinal symptoms with evidence of inebriation and developing metabolic acidosis. 1
Stage 2 – Critical Deterioration: The second phase consists of more severe metabolic acidosis and evidence of emerging renal injury, which, in the absence of appropriate supportive care, can lead to death.
Stage 3 – Delayed Complications: Final phase include various delayed neuropathies and other neurological effects, sometimes fatal.
Within days of severe DEG poisoning, patients can develop complete kidney failure, liver damage, and death.
The rapid progression from seemingly minor symptoms to multi-organ failure underscores why immediate medical intervention is essential when DEG exposure is suspected.
No, diethylene glycol is not safe in food or pharmaceutical products.
Following the 1937 tragedy, the FDA implemented strict regulations through the Federal Food, Drug, and Cosmetic Act (FD&C Act), requiring all drugs to be demonstrated safe before marketing². DEG has never received approval for use in food or medications.
Confusion arises because DEG is illegally substituted for safe, approved ingredients that it physically resembles. Unscrupulous manufacturers replace pharmaceutical-grade glycerin in syrups²,³ and propylene glycol (an FDA-approved food additive)³ with toxic DEG. Research indicates that paracetamol and other commonly used medicines are particularly likely to be contaminated with DEG during pharmaceutical processing³.
In 2023, recognizing the ongoing global threat, the FDA issued specific guidance titled "Testing of Glycerin for Diethylene Glycol" to alert the pharmaceutical industry about required raw material and finished drug testing to ensure safety⁵. This guidance emphasizes that preventing DEG contamination requires vigilant testing at multiple production stages, not merely trusting supplier certifications.
On October 8, 2025, India's Central Drugs Standard Control Organization (CDSCO) reported to the World Health Organization the presence of diethylene glycol in at least three oral liquid medicines⁴. This followed WHO's identification on September 30, 2025, of localized clusters of acute illness and child fatalities in India. The contaminated products were reportedly consumed by the affected children⁴.
The specific contaminated products identified were batches of COLDRIF (manufactured by Sresan Pharmaceuticals), Respifresh TR (manufactured by Rednex Pharmaceuticals), and ReLife (manufactured by Shape Pharma)⁴. CDSCO confirmed that relevant state authorities immediately ordered production halts at the implicated manufacturing sites, suspended product authorizations, and initiated recalls of contaminated products⁴.
Importantly, CDSCO informed both WHO and the FDA that none of the contaminated medicines were exported from India, and there is currently no evidence of illegal export⁴,⁵. The FDA confirmed these products have not been shipped to the United States⁵.
WHO has encouraged National Regulatory Authorities worldwide to consider targeted market surveillance, with particular attention to informal and unregulated supply chains where products may circulate undetected⁴. Authorities are advised to carefully evaluate risks associated with any oral liquid medicines originating from the same manufacturing sites, particularly those produced since December 2024⁴.
The FDA responded by reminding drug manufacturers that products intended for sale within the United States must meet current good manufacturing practice requirements and appropriate quality specifications⁵. The agency maintains strict safeguards to prevent unsafe drugs from being imported and continues coordinating with the World Health Organization to monitor the investigation⁵.
If you or your child experience symptoms that may be related to DEG poisoning, contact your healthcare professional immediately and inform them about any recent use of over-the-counter products, particularly imported medications⁵. Early recognition and supportive care can be life-saving.
Report any suspected contamination or adverse events to the FDA's MedWatch Safety Information and Adverse Event Reporting Program⁵. These reports help regulatory authorities identify patterns and prevent further harm.
Critical prevention measures include:
Obtain all medical products only from authorized and licensed suppliers⁴
Do not use any products identified in contamination alerts⁴
Be especially cautious with imported liquid medications
Note that the FDA does NOT recommend over-the-counter cough and cold medications for children younger than 2 years due to serious safety concerns⁵
Seek immediate medical attention if severe symptoms develop, if there has been recent use of imported liquid medications, or if a child shows unexplained kidney problems. Time is critical in DEG poisoning delayed treatment significantly worsens outcomes.
Diethylene glycol remains a serious and persistent public health threat, with the 2025 India outbreak serving as yet another tragic reminder of inadequate pharmaceutical quality control. Despite decades of documented mass poisoning events and hundreds of preventable deaths including over 300 fatalities in 2022-2023 alone, illegal DEG substitution continues driven by profit motives and regulatory gaps³.
While DEG has no legitimate place in pharmaceuticals or food, its physical similarity to safe excipients and significantly lower cost create ongoing temptation for unscrupulous manufacturers. Healthcare providers must maintain high suspicion for DEG poisoning when encountering unexplained acute kidney injury in children, particularly those recently treated with liquid medications. Parents should purchase medicines only from authorized suppliers, exercise caution with imported products, and immediately report suspected contamination to health authorities.
The fight against DEG contamination requires continued vigilance from manufacturers, regulators, healthcare professionals, and consumers. When in doubt about any medication's safety or source, always consult a qualified healthcare professional before use.
“It’s scary to think that something as simple as cough syrup can hide a deadly chemical. DEG contamination shows how one weak link in the supply chain can put lives at risk and reminds us that safety checks need to start from the very beginning,” said Vaishnavi Bondge in the discussion on MedBound Hub.
Schep LJ, Slaughter RJ, Temple WA, Beasley DM. Diethylene glycol poisoning. Clin Toxicol (Phila). 2009 Jul;47(6):525-35. doi: 10.1080/15563650903086444.
FDA. Guidance for Industry: Testing of Glycerin for Diethylene Glycol. Available at: https://www.fda.gov/media/167974/download
Rachman SS, Luthfi AM, Ardian SH, et al. Effects of diethylene glycol contamination of pharmaceutical products on unexplained acute kidney injury in children: a systematic review. doi:10.3345/cep.2023.01039
World Health Organization. Medical Product Alert N°5/2025: Substandard (contaminated) oral liquid medicines. 13 October 2025.
FDA Drug Safety Communication. FDA's actions to protect children from contaminated cough medicine. October 10, 2025.
Edited by M Subha Maheswari