NAFDAC discontinues multi-dose artemether/lumefantrine oral suspension
The National Agency for Food and Drug Administration and Control has reminded Nigerians that multi-dose artemether/lumefantrine dry powder for oral suspension is no longer approved for registration or use in the country.
The agency disclosed this in a statement issued on Friday, February 27, 2026, reaffirming an earlier regulatory directive released in 2025. It said the decision affects all locally manufactured and imported brands of the multi-dose anti-malaria suspension.
NAFDAC explained that the product was discontinued due to instability after reconstitution. According to the agency, once mixed with water, the drug becomes unstable and loses its effectiveness.
“This regulatory directive was taken due to the instability of the reconstituted formulations, which results in loss of efficacy of the suspension,” the agency stated.
It warned that reduced potency could lead to treatment failure, worsening illness, serious complications and, in severe cases, death.
The agency further announced that it no longer accepts new, renewal or variation applications for the multi-dose formulation. Manufacturers are now required to produce the medicine as dispersible tablets or single-dose powder or granules packaged in sachets.
NAFDAC said the directive applies to all manufacturers and importers of the affected product and advised healthcare workers and the public to report any sale of the discontinued medicine, as well as suspected substandard or counterfeit drugs.
