Maharashtra bans Coldrif cough syrup batch over safety concerns

The Maharashtra Food and Drug Administration ( FDA) on Sunday ordered an immediate halt to the sale, distribution, and use of Coldrif cough syrup belonging to batch number SR 13, citing safety concerns.

In an official press, the state regulator said the action follows reports of the tragic deaths of children in Madhya Pradesh and Rajasthan, allegedly linked to the use of Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup) from the same batch.

This marks the fourth state that took the action after Madhya Pradesh, Kerala and Tamil Nadu. Telangana has also issued an alert to the public to stop using the cough syrup.

Preliminary findings suggest the product may have been adulterated with Diethylene Glycol (DEG) — a toxic industrial chemical known to cause severe poisoning.

The syrup, manufactured by Sresan Pharma based in Sunguvarchathiram, Kancheepuram district of Tamil Nadu, was produced in May 2025 and carries an expiry date of April 2027, according to the government notice.

“All licensees and members of the public are hereby instructed to immediately stop the sale, distribution, and use of Coldrif Syrup, Batch No. SR-13, and report any stocks to the local Drug Control Authorities without delay,” the FDA said in the alert.

The department has further urged the public to report possession of the said batch through its toll-free helpline (1800-222-365) or by email at jchq.fda-mah@nic.in, or by contacting 9892832289..

"All Drugs Inspectors and Assistant Commissioners have been instructed to immediately alert retailers, wholesalers, and hospitals to freeze any stocks of the said product batch if available in the market," the memo also read.