The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying Healthcare providers and the public of three substandard (contaminated) oral liquid medicines identified in India and reported to WHO on 8 October 2025.
The contaminated oral liquid medicines have been identified to be specific batches of COLDRIF, Respifresh TR, and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma.
The Central Drugs Standard Control Organization (CDSCO) of India reported to WHO the presence of Diethylene Glycol (DEG) in the above-mentioned products. This report followed information identified by WHO on 30 September 2025 of localized clusters of acute illness and child fatalities in India. According to the CDSCO, the contaminated products were reportedly consumed by the affected children.
CDSCO has confirmed that relevant state authorities in India have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorizations. In addition, a recall of the contaminated products has been initiated by the relevant state authorities.
The affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of the common cold, flu, or cough.
Diethylene glycol and ethylene glycol are toxic to humans when ingested and can be fatal. The toxic effects may include abdominal pain, vomiting, diarrhoea, difficulty urinating, headache, altered mental state, and acute kidney injury, which can result in death.
Risk Statement
The contaminated oral liquid medicines mentioned in this alert are unsafe, and their use, especially in children, may result in serious injury or death. They are considered substandard as they fail to meet their quality standards and specifications.
Product Details
The details of the affected products are as follows.
Product | COLDRIF | Respifresh TR | ReLife |
Stated API | Paracetamol, chlorpheniramine maleate, phenylephrine, sodium citrate | Bromhexine hydrochloride, terbutaline sulphate, guaiphenesin, menthol | Ambroxol HCL, guaiphenesin, terbutaline sulphate, menthol |
Manufacturer | Sresan Pharmaceutical manufacturer, No. 787, Bangalore Highways, Sunguvarchatraam (Mathura) Kancheepuram, Dist. 602106 | Rednex Pharmaceutical Pvt Ltd. Survey No. 586 & 231, NR. SKF Bearing Bavla Bagodra N.H. 8A Kerala, Tal, Bavla, Dist. Ahmedabad-383220 Gujarat |
Shape Pharma Pvt. Ltd. Plot No. 4, Surendranagar Rajkot Highway Rd. Shekhpur 363510 Gujarat |
Batch | SR-13 | R01GL2523 | LSL25160 |
Date of manufacture | 05/2025 | 01/2025 | 01/2025 |
Expiry date | 04/2027 | 12/2026 | 12/2026 |
Contamination* | 48.6% w/v DEG | 1.34% w/v DEG | 0.61% w/v DEG |
Photos | No available photos currently. | ||
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard products if found within the zones and states.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC………. Customer-focused, Agency-minded!!!
