Maharashtra FDA Halts Coldrif Syrup Over Fatal Contamination Reports

The Maharashtra Food and Drugs Administration (FDA) announced on October 5, 2025, an immediate suspension of the sale, distribution, and use of Coldrif Syrup. This decision follows reports of child fatalities in Madhya Pradesh and Rajasthan allegedly linked to the product. The affected batch, identified as Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate), Batch No. SR-13, was manufactured by Sresan Pharma in May 2025 and is set to expire in April 2027.

Laboratory tests revealed the presence of Diethylene Glycol (DEG), a toxic substance commonly found in industrial products, including antifreeze. Ingestion of DEG can lead to severe health complications, including kidney failure, and has been associated with multiple deaths.

D.R. Gahane, Drug Controller of the Maharashtra FDA, emphasized that the state remains safe. “We held a meeting with the Drug Control Authorities in Tamil Nadu to trace the distribution of the batch in Maharashtra. They have confirmed that Coldrif cough syrups were not supplied in Maharashtra. It is challenging to trace if someone traveled from Maharashtra to Madhya Pradesh or other locations and purchased the syrup there,” he stated. The FDA’s advisory aims to prioritize public safety.

In response to the advisory, the FDA has instructed all pharmacies, hospitals, wholesalers, and license holders to cease handling the implicated batch immediately. Stakeholders are required to report any remaining stock to local drug control authorities. Citizens are encouraged to report possession of Coldrif Syrup through a toll-free number, email, or mobile contact provided by the FDA.

The FDA has deployed drug inspectors and assistant commissioners to inform market stakeholders and to ensure that any remaining stock of Coldrif Syrup is frozen. The Central Drugs Standard Control Organisation (CDSCO) is anticipated to take stringent action against the manufacturer and has requested Tamil Nadu’s FDA to initiate proceedings.

Actions taken by other states reflect the seriousness of the situation. Madhya Pradesh has implemented a complete ban on the syrup after several child fatalities in Chhindwara district. In Rajasthan, the state drug controller has been suspended, and the distribution of all medicines from another manufacturer, Kaysons Pharma, has been halted. An expert committee has been formed in Rajasthan to investigate the matter further.

In light of these events, the Union Health Ministry has recommended that cough and cold medications not be prescribed for children under two years of age. They have also issued guidance to health departments across all states and Union Territories regarding the use of such medications.

The FDA’s swift response and the collaborative efforts among various state health authorities demonstrate a commitment to safeguarding public health in the wake of this alarming situation.