Regulatory Affairs
NAFDAC Places Mofus Nigeria Products on Watchlist Pending Regulatory Investigation
NAFDAC has placed products marketed by Mofus Nigeria Ltd on its watchlist following findings of significant regulatory non-compliance and potential misrepresentation, with an investigation now underway.
The National Agency for Food and Drug Administration and Control (NAFDAC) has placed products marketed by Mofus Nigeria Ltd on its watchlist pending the outcome of an ongoing regulatory investigation into alleged regulatory non-compliance and potential misrepresentation.
In a Public Alert No. 043/2026, released on 19 August 2026, the agency said the investigation involves products associated with Mofus Nigeria Ltd, Ayrtons Saunders Ltd, United Kingdom, and Pharmaserve (North West) Ltd.
NAFDAC said the case is registered under reference number NAFDAC/PMS/2026/0029 and remains under active investigation.
NAFDAC identifies high-risk regulatory case
According to the agency, the investigation followed findings of significant regulatory non-compliance and potential misrepresentation associated with the affected products.
NAFDAC's regulatory information identifies Ayrtons Saunders Ltd as the product/entity name, Pharmaserve (North West) Ltd as the manufacturer and Mofus Nigeria Ltd as the marketing authorisation holder.
The products are listed as registered, while the regulatory case has been assigned a high risk level and remains under investigation.
NAFDAC said it has activated continuous surveillance and issued notifications to relevant stakeholders as part of its regulatory response.
The agency has also encouraged healthcare professionals, distributors and members of the public to report any quality concerns or irregularities involving the affected products.
What NAFDAC is asking pharmacists and medicine suppliers to do
NAFDAC has advised healthcare professionals, distributors, wholesalers, retailers, Patent and Proprietary Medicine Vendors (PPMVs), healthcare institutions and members of the public to exercise vigilance when procuring, distributing, dispensing or using products marketed by Mofus Nigeria Ltd.
The agency specifically advised stakeholders to purchase medical products only from licensed and authorised suppliers and to maintain complete distribution records to support traceability where necessary.
Healthcare facilities, pharmacists, distributors and medicine vendors have also been asked to cooperate with regulatory activities connected to the investigation.
Importantly, the alert does not state that all products marketed by Mofus Nigeria Ltd have been declared counterfeit or substandard. The agency's current action is a watchlist measure pending the conclusion of its investigation.
NAFDAC urges reporting of suspected quality problems
NAFDAC is also asking healthcare professionals and consumers to report suspected cases involving substandard or falsified medicines and medical devices, as well as product authentication concerns and other regulatory irregularities.
Adverse events and suspected side effects associated with medicines or medical devices can also be reported through NAFDAC's pharmacovigilance channels and its Med Safety application.
The agency said such reports are important to its post-marketing surveillance activities and regulatory interventions.
Why the alert matters to pharmacy practice
The development highlights the role of pharmacists and other medicine-supply stakeholders in maintaining traceability and product quality throughout the pharmaceutical supply chain.
For pharmacies, hospitals, wholesalers and medicine vendors, NAFDAC's advice reinforces the importance of sourcing medicines through authorised channels, retaining appropriate purchasing and distribution records, and promptly escalating suspected quality or regulatory concerns.
The outcome of the ongoing investigation will determine whether further regulatory action is required against the affected products or entities.
Until then, NAFDAC has urged stakeholders to remain vigilant and cooperate with the agency's surveillance and investigation activities.