ThePharmacy and Medicines Regulatory Authority (PMRA) is informing stakeholders and the public that the World Health Organisation (WHO) has issued an alert concerning three substandard (contaminated) oral liquid medicines identified in India and reported to WHO on 8th October, 2025.
The affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of the common cold, flu, or cough. The contaminated oral liquid medicines have been identified to be specific batches of COLDRIF, Respifresh TR and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively. The three products are considered substandard as they fail to meet their quality standards and specifications, making them unsafe.
According to WHO, none of the contaminated oral liquid medicines have been exported from India and that there is no evidence of illegal export.
PMRA is assuring stakeholders and the public that none of the three manufacturers have registered their products with PMRA making it very unlikely for the contaminated batches to be available in the country. However, in case anyone has these products, PMRA recommends that they should not use them and report to the Authority immediately.
PMRA urges pharmaceutical importers, retailers, healthcare workers, and consumers to report any suspected substandard or falsified medicines or adverse drug reactions to any healthcare facility and to the PMRA.
The Authority remains committed to ensuring medicines and allied substances in the country meet quality, safety, and efficacy standards as mandated by the PMRA Act, 2019.
Full details of the alert are available on: Medical Product Alert N°5/2025
For media enquiries, please contact PMRA Public Relations Officer on +265 899 567 365 or email at jjosiah@pmra.mw