The National Agency for Food and Drug Administration and Control (NAFDAC) has again warned Nigerians that multi-dose Artemether/Lumefantrine dry powder for oral suspension is no longer approved for use or registration in the country.
The agency issued the reminder in a statement released on Friday, February 27, 2026. It referred to an earlier directive announced in 2025.
NAFDAC said the ban covers all brands of the product, whether manufactured locally or imported.
The agency explained that the decision followed concerns about the stability of the drug after it is mixed with water. It stated that the medicine becomes less effective once reconstituted.
“This regulatory directive was taken due to the instability of the reconstituted formulations, which results in loss of efficacy of the suspension,” the agency said.
NAFDAC added that research has shown that a reduction in the drug’s strength can prevent proper treatment of malaria. It warned that such a situation may lead to treatment failure, worsening health conditions, serious complications, and even death in severe cases.
The agency also announced that it no longer processes applications related to the product. This includes new registrations, renewals, and variations.
Manufacturers have now been directed to produce the medication in alternative forms such as dispersible tablets or single-dose powders or granules packaged in sachets.
“This directive applies to all manufacturers and importers of multi-dose Artemether/Lumefantrineb dry powder for oral suspension,” the agency added.
NAFDAC urged healthcare providers and the general public to report any circulation or sale of the banned product. It also encouraged reporting of suspected fake or substandard medicines.
