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The National Agency for Food and Drug Administration and Control (NAFDAC) has released a clarification to explain its recent publication of 101 drug products that have been withdrawn, suspended, or cancelled.
In a statement signed by the agency’s Director-General, Professor Mojisola Adeyeye, NAFDAC said the explanation became necessary to guide Nigerians and prevent confusion about the regulatory status of the affected medicines. The move, according to the agency, aims to enhance public awareness, promote transparency, and protect public health.
Professor Adeyeye noted that the clarification outlines the meaning and implications of the three classifications — withdrawn, suspended, and cancelled — to help manufacturers, distributors, and consumers understand how each category affects product availability and regulatory standing.
According to NAFDAC, a product labelled as “withdrawn” means that the company has voluntarily discontinued it, often for business or market reasons and not necessarily due to safety or quality issues. Examples include Artemether/Lumefantrine 40mg/240mg tablets by Healthline Limited and ASAQ (Artesunate Amodiaquine Winthrop) tablets by Sanofi Aventis Nigeria Ltd, which were withdrawn for commercial reasons.
The “suspended” classification applies when NAFDAC temporarily halts a product’s registration due to non-compliance with regulatory standards. Such suspensions remain in effect until the manufacturer addresses identified issues and meets the required compliance standards.
Products that have been “cancelled” have had their registration completely revoked. This means such products are no longer approved for manufacturing, importation, sale, or use in Nigeria. NAFDAC said cancellation usually follows serious concerns over product safety, poor manufacturing practices, or quality control failures.
Professor Adeyeye added that publishing lists of withdrawn, suspended, or cancelled products is a global regulatory best practice designed to safeguard consumers and prevent the circulation of unsafe or counterfeit medicines.
Among the 101 affected medicines, some popular brands are included. Flagyl Suspension and Flagyl Tablets (400mg) have been delisted, meaning they are no longer approved for sale or use in Nigeria, although other metronidazole-based medicines remain available.
In the antimalarial category, Artemether/Lumefantrine and ASAQ tablets were voluntarily withdrawn by their manufacturers.
In the antimicrobial segment, Penicillin G Sodium Sandoz Powder (1,000,000 IU) was voluntarily withdrawn by Novartis Nigeria Ltd, while Elisa Eye Drops (Chloramphenicol) had its registration cancelled for failing to meet regulatory standards.
For diabetes treatment, Januvia (50mg and 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg, 2mg, and 4mg SR) were all withdrawn from the Nigerian market. Other affected drugs include Aprovasc (150mg/5mg), Coaprovel (300mg/25mg), and Abacavir Sulfate/Lamivudine (60mg/30mg) tablets.
The list also features Norditropin Growth Hormone Injectables and Insulin Injectables, which were delisted after further regulatory reviews. Similarly, Cryomarex Rispens HVT Vaccine was removed from NAFDAC’s approved register following safety assessments.
NAFDAC said the update comes amid intensified efforts to rid the Nigerian market of fake, expired, and substandard products. In October 2025, the agency destroyed counterfeit and expired drugs worth more than ₦15 billion in Ibadan, Oyo State. The destroyed items included Analgin, Co-codamol, codeine syrups, Tramadol, Oxytocin, and expired vaccines.
In one notable case, NAFDAC intercepted a container falsely labelled as diclofenac, which actually contained over 100,000 anti-malaria tablets packed into 277 cartons.
A month earlier, in September 2025, the agency uncovered another illegal operation in Ilasa-Oshodi, Lagos, where unregistered Malamal Forte malaria medicines worth ₦1.2 billion were seized from a warehouse. The products were disguised in cartons marked as Diclofenac Potassium.
At the Trade Fair market in Lagos, officials also confiscated banned, expired, and unregistered cosmetics worth over ₦1.5 billion. Many of the goods were smuggled into the country without safety clearance, while an entire truckload of fake products was also intercepted.
NAFDAC reaffirmed its commitment to enforcing pharmaceutical regulations, warning importers and distributors against the sale of unapproved or unregistered medicines. The agency said it would continue nationwide surveillance to ensure that only safe, high-quality, and effective medical products are available to Nigerian consumers.