Maharashtra residents are secure as no Coldrif syrup is provided within the State, says FDA

The Maharashtra Food and Drug Administration (FDA) urged the general public on Monday (October 6, 2025) to right away cease the sale and use of a particular batch of the Coldrif syrup, following experiences of kid deaths in Madhya Pradesh and Rajasthan, allegedly linked to the medication.

The attraction comes amid rising issues over an adulterated batch of the syrup. The FDA had issued an pressing advisory earlier on Sunday (October 5, 2025), calling for the speedy suspension of sale, distribution, and use of Coldrif Syrup.

The affected lot (Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate), Batch No. SR-13) was manufactured in May 2025 by Sresan Pharma, primarily based in Sunguvarchatram, Kancheepuram district, Tamil Nadu. The batch is about to run out in April 2027. Laboratory evaluation revealed the presence of Diethylene Glycol (DEG), a poisonous chemical generally present in industrial merchandise resembling anti-freeze. Ingestion of DEG may cause kidney failure and has been linked to a number of deaths.

Speaking to The Hindu, FDA Joint Commissioner (Drugs) D.R. Gahane stated, “Our State and residents are secure. We held a gathering with the Drug Control Authorities in Tamil Nadu to hint the distribution of the batch in Maharashtra. They confirmed that Coldrif cough syrups weren’t provided within the State. It is tough to hint whether or not somebody travelled from Maharashtra to neighbouring States, purchased the cough syrup and introduced it right here. Nevertheless, we issued the assertion within the public curiosity and security.”

The FDA has instructed all pharmacies, hospitals, wholesalers, and license holders to right away cease dealing with the affected batch and report any inventory to native drug management authorities. Citizens can even report possession of the syrup through the toll-free quantity: 1800222365, electronic mail ID: jchq.fda-mah@nic.in, or cellular: 9892832289.

Drug Inspectors and Assistant Commissioners have been deployed to alert market stakeholders and guarantee any remaining inventory stays frozen. The Central Drugs Standard Control Organisation (CDSCO) is predicted to take strict motion towards the producer and has requested Tamil Nadu’s FDA to do the identical.

The public alert additionally acknowledged that every one licensees and customers are instructed to right away cease the sale, distribution or use of Coldrif Syrup, Batch No. SR-13, and report these in possession of the syrup to the native Drugs Control Authorities at once.

The incident has triggered responses throughout a number of States. Madhya Pradesh has imposed an entire ban on the syrup following the deaths of a number of youngsters in Chhindwara district. Rajasthan has suspended its State drug controller and halted the distribution of all medicines from one other producer, Kaysons Pharma, whereas forming an skilled committee to analyze.

The Union Health Ministry has additionally really helpful that cough and chilly medicines not be prescribed to youngsters underneath two years of age and has issued steering to well being departments throughout all States and Union Territories.