Maharashtra FDA Issues Urgent Ban On Cold-Ref Cough Syrup Batch Sr-13 After Child Deaths

Mumbai: Maharashtra’s Food and Drug Administration (FDA) has issued an urgent alert following the deaths of children in Madhya Pradesh and Rajasthan linked to Cold-Ref (Coldrif) cough syrup. The agency has called for an immediate ban on batch SR-13 of the syrup after laboratory tests revealed dangerously high levels of toxic chemicals.

According to FDA Drug Controller D.R. Gahane, testing of batch SR-13, manufactured by Sresan Pharmaceuticals in Tamil Nadu, showed the presence of 48.6% diethylene glycol (DEG). DEG is a hazardous chemical commonly used in antifreeze and brake fluids. Ingesting it can lead to kidney failure and even death, raising serious public health concerns.

Maharashtra FDA restricts sale, distribution and use of Coldrif syrup Batch no SR 13 with immediate effect. Those who are possession, have been instructed to report it to Drug Control Authorities pic.twitter.com/YrSHJMjE3A

— ANI (@ANI) October 5, 2025

Following the detection, states including Maharashtra, Kerala, and Telangana have suspended sales of the syrup, recalled existing stock, and issued public advisories urging parents to stop using the affected batch immediately. The FDA has instructed all drug inspectors across Maharashtra to seize the syrup, halt sales, and submit samples for testing to ensure no further distribution occurs.

Parents and the public are urged to check their medicine cabinets and report any remaining stock of Cold-Ref batch SR-13 to local drug control authorities. For assistance, the FDA has set up a toll-free helpline at 1800-222-365, along with an email address: jchq.fda-mah@nic.in and a mobile number: 9892832289.

Authorities have warned that even small amounts of the syrup can be fatal, especially for children, and stressed that immediate action is necessary to prevent further casualties. This alert comes amid increasing scrutiny of cough syrup safety across the country, following multiple child deaths in other states. The FDA has assured the public that strict action will be taken against manufacturers and distributors of unsafe pharmaceutical products.

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