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The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a clarification on the status of 101 withdrawn drugs.
A statement released on its official X handle on Tuesday, the agency said the move is to help the public and stakeholders better understand the status and implications of each product category listed.
According to NAFDAC, the terms “withdrawn,” “suspended,” and “cancelled” describe distinct regulatory actions taken to ensure drug quality, safety, and compliance.
Under the clarification, “withdrawn” refers to products whose registration was voluntarily discontinued by the marketing authorisation holder, often for commercial or market-related reasons and not necessarily linked to safety concerns.
“Suspended” denotes temporary halts in registration pending regulatory compliance, while “cancelled” applies to products whose approvals have been fully revoked and are no longer authorised for manufacture, importation, or sale — often due to safety, quality, or poor manufacturing practices.
The agency explained that publishing such lists followed global best practices aimed at preventing counterfeiting and ensuring that delisted products do not remain in circulation.
NAFDAC listed examples across several categories, including antimalarials, antimicrobials, diabetes medicines, eye drops, and injectables.
Among the affected products were Artemether/Lumefantrine 40mg/240mg Tablets and ASAQ (Artesunate Amodiaquine Winthrop) Tablets, both withdrawn voluntarily by Healthline Limited and Sanofi Aventis Nigeria Ltd, respectively, for commercial reasons.
Other affected drugs included Flagyl Suspension and Tablets (400mg), which are no longer approved for manufacture or sale, and Norditropin Growth Hormone Injectables, which have been delisted following regulatory review.
In the diabetes category, Januvia and Janumet have been withdrawn from the market, while Amaryl M Tablets and Amaryl M SR were voluntarily withdrawn by Sanofi Aventis Nigeria Ltd.
NAFDAC reaffirmed its commitment to public safety.
“NAFDAC remains committed to safeguarding the health of Nigerians through continuous post-market surveillance and regulatory enforcement to ensure that only safe, quality, and efficacious products are available to the public”, it said.
