The National Agency for Food and Drug Administration and Control has again warned that multi-dose Artemether/Lumefantrine dry powder meant for oral suspension remains barred from registration and use in Nigeria.
In a statement issued on Friday, the 27th of February, 2026, the agency drew attention to an earlier regulatory decision announced in 2025, stressing that the position has not changed.
NAFDAC said the restriction covers every brand of the multi-dose anti-malaria suspension, whether produced within the country or brought in from abroad.
The agency stated that the withdrawal followed findings that the product does not remain stable after it is mixed with water. Once reconstituted, it was found to lose potency over time.
“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.
It added that research indicates that reduced potency can prevent the drug from effectively treating malaria. Such treatment gaps, it warned, may result in prolonged sickness, failed therapy, severe health complications and, in extreme situations, death.
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NAFDAC also made clear that it has stopped processing fresh applications, renewals, or variations relating to the affected formulation.
Pharmaceutical companies have been directed to manufacture Artemether/Lumefantrine either as dispersible tablets or as 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.
The regulator urged health professionals and the general public to alert authorities if the discontinued products are still being sold, and to report any suspected counterfeit or substandard medicines.