NMRA Orders Immediate Recall of Ondansetron Batches Over Safety Concerns

Date:

December 15, Colombo (LNW): The National Medicines Regulatory Authority (NMRA) has ordered the immediate suspension of four batches of Ondansetron injections, a widely used drug prescribed to control nausea and vomiting in children, expectant mothers and patients undergoing surgical procedures.

In a directive issued on December 12, 2025, the NMRA said the decision was taken following reports of adverse reactions associated with the medicine.

The manufacturer has been instructed to submit a detailed explanation within a period of 28 days, while the affected batches are removed from circulation.

Commenting on the development, Dr Chamal Sanjeewa, Chairman of the Doctors’ Trade Union Alliance for Medical and Civil Rights, reiterated longstanding concerns about medicines approved under the Indian Pharmacopoeia.

He noted that several such products imported in recent years had later been withdrawn due to quality failures, and criticised the Health Ministry for permitting their use in public hospitals without further independent testing. He warned that substandard drugs pose both health risks to patients and financial losses to the state.

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