NAFDAC withdraws multi-dose malaria drugs due to instability risks
NAFDAC has issued a directive to immediately withdraw all multi-dose Artemether/Lumefantrine dry powder for oral suspension products from circulation in Nigeria. The agency reiterated that these products are no longer approved for registration, importation, or use, citing instability in reconstituted suspensions that reduces efficacy and poses serious health risks including treatment failure and potential death. Manufacturers and importers must switch production to dispersible tablets or single-dose sachets immediately. Affected brands include Bellartem, Lokmal, HAVAX, PALUDEX, WINART, BIOLUMEFAR, FANETHA, Artemelum, and Cikatem. All zonal directors and state coordinators are instructed to remove remaining products from markets. Consumers and healthcare professionals should report suspected substandard products or adverse effects to NAFDAC via their Med-safety app or email. This directive follows a February 27, 2025 public alert and comes amid a series of safety warnings about substandard medical products in Nigeria.