The National Agency for Food and Drug Administration and Control (NAFDAC) has restated its directive discontinuing the registration of multi-dose Artemether/Lumefantrine dry powder for oral suspension, citing concerns over the drug’s instability and reduced effectiveness after reconstitution.
In Public Alert No. 09/2026, the agency reminded the public that the regulatory decision, first announced in February 2025, affects all locally manufactured and imported multi-dose Artemether/Lumefantrine dry powder products used in the treatment of malaria.
NAFDAC said findings from stability studies revealed that once the powder is mixed with water, the anti-malarial suspension becomes unstable and may lose its potency. According to the agency, reduced efficacy could lead to treatment failure, worsening illness, increased risk of complications, delayed recovery and, in severe cases, death.
As part of the enforcement measures, NAFDAC stated that it will no longer process new applications, renewals or variations for the affected products. Manufacturers have been advised to switch to safer alternatives such as dispersible tablets or single-dose powders or granules packaged in sachets.
The directive applies to all brands, manufacturers and importers of the multi-dose Artemether/Lumefantrine dry powder oral suspension.
The agency urged healthcare professionals and members of the public to report any suspected circulation or sale of the discontinued products, as well as substandard or falsified medicines, to the nearest NAFDAC office. Reports can also be submitted through the agency’s helpline or official email channels.
NAFDAC said the renewed warning is part of its broader efforts to protect public health and ensure the continued effectiveness of malaria treatment nationwide.