NAFDAC Bans Multi-Dose Malaria Suspension Over Potency Concerns

The National Agency for Food and Drugs Administration and Control (NAFDAC), has reiterated its directive discontinuing the registration of all multi-dose Artemether/Lumefantrine dry powder for oral suspension, citing concerns over reduced effectiveness after reconstitution.

In a fresh public reminder (Public Alert No. 09/2026), the agency stressed that stability studies revealed the reconstituted anti-malarial formulations rapidly lose potency, potentially undermining treatment outcomes and exposing patients to serious health risks.

NAFDAC clarified that the directive, first issued in February 2025, applies to both locally manufactured and imported multi-dose Artemether/Lumefantrine suspensions.

Consequently, the agency has stopped accepting new applications, renewals, or product variations related to the formulation.

The regulator warned that medicines that lose efficacy can lead to prolonged illness, complications, delayed recovery, and in extreme cases, death, underscoring the need for strict compliance with the directive.

To ensure continued access to effective malaria treatment, NAFDAC advised manufacturers to transition to safer alternatives such as dispersible tablets or single-dose powder or granule sachets for oral use.