NAFDAC bans popular malaria suspensions over safety concerns

The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered the immediate halt of sale and use of all multi-dose Artemether/Lumefantrine dry powder for oral suspension — a common anti-malaria medicine used for children.

In a new public alert, the agency warned that the multi-dose versions of the drug become unstable after they are mixed with water, leading to a loss of effectiveness.

Artemether/Lumefantrine is one of the most widely used treatments for malaria in Nigeria. It is often given to children in liquid form after caregivers mix the powder with water.

But NAFDAC says stability studies show that once reconstituted, the suspension does not remain effective. When a malaria drug loses its strength, it may fail to properly treat the infection.

The agency warned that reduced effectiveness can lead to worsening illness, increased risk of complications, delayed recovery and in severe cases, death.

Because malaria remains one of Nigeria’s most common and deadly diseases, the directive is considered highly significant for families and healthcare providers.

What Products Are Affected?

The directive applies to all brands of multi-dose Artemether/Lumefantrine dry powder for oral suspension, both locally made and imported products.

NAFDAC said it will no longer approve new registrations, renewals or variations for the affected products.

Manufacturers have instead been directed to produce dispersible tablets, or single-dose sachets of powder or granules. These formats are considered more stable and safer.

Products Still in Circulation

Despite an earlier directive issued in February 2025, NAFDAC says surveillance reports show that the banned products are still being sold in some states.

The agency has now directed its zonal directors and state coordinators nationwide to begin enforcement operations to remove the products from circulation.

Anyone who sees the products being sold or suspects substandard medicines is urged to report to the nearest NAFDAC office or call 0800-162-3322. Reports can also be made via email at sf.alert@nafdac.gov.ng.

Healthcare workers and patients are also encouraged to report any side effects through NAFDAC’s official reporting platforms.