Maharashtra FDA flags Coldrif syrup batch linked to child deaths

The FDA Maharashtra further said it is taking all necessary measures to safeguard public health and prevent any further risk to life.

The Maharashtra FDA on Monday appealed to the people to immediately stop the sale or use of a specific batch of Coldrif syrup, following child deaths in Madhya Pradesh and Rajasthan allegedly linked to the medicine.

Earlier, the Tamil Nadu drug control authorities, in their report of October 2, declared the Coldrif syrup sample (Batch No SR-13; Mfg: May 2025; Exp: April 2027) manufactured by Sresan Pharmaceuticals, Kancheepuram, as adulterated because it contained diethylene glycol (48.6% w/v), a poisonous substance "which may render the contents injurious to health".

As many as 14 child deaths have been reported from Madhya Pradesh's Chhindwara district due to suspected renal failure, linked to the consumption of the “toxic” cough syrup.

"The public is urged to remain cautious and to report any possession of Coldrif Syrup Batch No. SR-13 to the nearest Drugs Control Authority without delay," the Maharashtra Food and Drug Administration (FDA) said in a statement on Monday.

It warned that the batch is suspected to be adulterated with diethylene glycol, a toxic chemical.

The FDA officials said they are coordinating with the Tamil Nadu Drugs Control Administration to trace the distribution of the affected batch in Maharashtra.

All drug inspectors and assistant commissioners have been directed to alert retailers, wholesalers and hospitals to immediately freeze any available stock, the statement said.

The FDA Maharashtra further said it is taking all necessary measures to safeguard public health and prevent any further risk to life.

The syrup, containing Phenylephrine Hydrochloride and Chlorpheniramine Maleate, was produced by Sresan Pharma at Sunguvarchathram in Tamil Nadu's Kancheepuram district, the statement said.