NAFDAC has issued a fresh public alert reminding manufacturers, importers, distributors, healthcare providers, and the general public of its standing regulatory decision to discontinue the registration of multi-dose Artemether/Lumefantrine dry powder for oral suspension in Nigeria.
The reminder, contained in Public Alert No. 09/2026, reinforces the agency’s directive that multi-dose formulations of Artemether/Lumefantrine oral suspension are no longer approved for registration or use, citing public health and safety concerns. The affected products are commonly prescribed as paediatric antimalarial medicines.
The regulatory action is part of NAFDAC’s broader effort to strengthen drug safety standards, particularly for paediatric medicines, where dosing accuracy and product stability are critical. The agency stressed that single-dose, co-blister, or fixed-dose combination alternatives remain the preferred and approved treatment options in line with global best practices.
According to the regulator, the continued circulation or use of discontinued multi-dose Artemether/Lumefantrine suspensions may pose risks, including improper dosing, reduced efficacy, contamination after reconstitution, and non-compliance with updated malaria treatment guidelines.
NAFDAC directed all pharmaceutical companies and marketers to immediately halt the production, importation, distribution, sale, and promotion of the affected products. Healthcare professionals have also been advised to stop prescribing the discontinued formulations and switch patients to approved alternatives.
The agency further urged members of the public to report any sightings of the banned multi-dose products in pharmacies, hospitals, or open markets, while warning that enforcement actions, including product seizure and sanctions, will be applied against violators.
NAFDAC reaffirmed its commitment to safeguarding public health and ensuring that only safe, effective, and quality-assured medicines remain in circulation across Nigeria, particularly as the country continues its fight against malaria.
