Media release – Recall of affected batches of multiple products following safety concerns
The Pharmacy and Medicines Regulatory Authority (PMRA) is informing stakeholders and the general public that it has received product recall alerts issued by the Pharmacy and Poisons Board (PPB) of Kenya and the South African Health Products Regulatory Authority (SAHPRA). These alerts concern specific batches of several pharmaceutical products manufactured by companies that are also registered to supply the Malawi market. The recalls have been initiated following the identification of quality and safety concerns.
Full statement is available here.
WHO alert on substandard (contaminated) oral liquid medicines
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
WHO alert on falsified Oxymorphone hydrochloride 40mg tablets
The Pharmacy and Medicines Regulatory Authority (PMRA) is informing stakeholders and the general public that the World Health Organisation (WHO) has issued an alert concerning one batch of falsified (contaminated) Oxymorphone Hydrochloride 40mg tablets. The falsified product was detected in the unregulated supply chain in Finland and reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA).
Oxymorphone Hydrochloride is a semi-synthetic opioid used to treat moderate to severe pain.
The falsified product imitates Oxymorphone Hydrochloride marketed by AUROLIFE PHARMA LLC., who have confirmed that the product, subject of this Alert, is falsified and was not produced by their company.
PMRA is assuring stakeholders and the general public that Oxymorphone Hydrochloride is not registered with the Authority, making it very unlikely for the falsified product to be available in the country.
However, in case anyone has the affected product, PMRA recommends that they should not use it and report to the Authority immediately.
PMRA urges pharmaceutical importers, retailers, healthcare workers, and consumers to report any suspected falsified medicines or adverse drug reactions to any healthcare facility and to the PMRA by dialing *360# for free on TNM and Airtel networks.
The Authority remains steadfast in ensuring that medicines and allied substances being used in the country are of acceptable quality, safe and efficacious in line with our mandate as provided for under the PMRA Act, 2019.
Full details of the alert are available on: Medical Product Alert N°3/2024
For media enquiries, please contact PMRA Public Relations Officer on +265 899 567 365 or email at jjosiah@www.pmra.mw