The National Agency for Food and Drug Administration and Control (NAFDAC) has explained why it withdrew, suspended, and cancelled the registration of 101 drugs across Nigeria. 

The agency said the move was to protect public health and clear any confusion about the regulatory status of these medicines.

According to a statement signed by NAFDAC’s Director-General, Prof. Mojisola Adeyeye, the clarification became necessary after the agency published a list of affected products. 

She said the decision followed global best practices aimed at ensuring that only safe, high-quality, and approved medicines remain on the market.

What the classifications means

NAFDAC grouped the affected drugs into three categories, withdrawn, suspended, and cancelled, each with a different meaning.

• Withdrawn: This means a company has voluntarily stopped producing or selling a product. The reason is usually business-related, not necessarily due to safety concerns. For example, Artemether/Lumefantrine 40mg/240mg tablets by Healthline Limited and ASAQ (Artesunate Amodiaquine Winthrop) by Sanofi Aventis Nigeria Ltd were withdrawn for commercial reasons.
• Suspended: A suspension occurs when NAFDAC temporarily halts a product’s registration because the manufacturer failed to meet certain regulatory or quality standards. The product can return to the market once all issues are resolved.
• Cancelled: This is the most serious category. It means the product’s registration has been completely revoked and can no longer be made, imported, or sold in Nigeria. Cancellations often happen when a product is unsafe, poorly manufactured, or fails quality checks.

Prof. Adeyeye said publishing such lists helps prevent counterfeit and unsafe medicines from staying in circulation, a practice adopted by many health regulators globally.

Notable products on the list

Some familiar names appeared among the affected products.

• Flagyl Suspension and Tablets (400mg) were cancelled and are no longer approved for sale, although other Metronidazole forms remain registered.
• Januvia, Janumet, and Amaryl M — popular diabetes drugs were withdrawn from the Nigerian market.
• Penicillin G Sodium Sandoz Powder (1,000,000 IU) was voluntarily withdrawn by Novartis Nigeria Ltd.
• Elisa Eye Drops (Chloramphenicol) was cancelled for failing to meet regulatory standards.
• Other products like Aprovasc, Coaprovel, Abacavir Sulfate/Lamivudine, Norditropin Growth Hormone, Insulin Injectables, and Cryomarex Rispens HVT Vaccine were also delisted after reviews.

NAFDAC said the public should not panic, adding that the action was taken to ensure safer alternatives remain available in the market.

The crackdown on fake and expired products

NAFDAC also linked the move to its broader fight against fake, expired, and unregistered drugs across the country.

In October, the agency destroyed counterfeit and expired medical products worth over ₦15 billion in Ibadan. The destroyed items included Tramadol, Codeine cough syrups, Analgin, Co-codamol, Oxytocin, and expired vaccines.

A similar operation in Lagos uncovered unregistered malaria medicines worth about ₦1.2 billion hidden in a warehouse and falsely labelled as Diclofenac Potassium. NAFDAC also seized banned and expired cosmetics worth ₦1.5 billion from the Trade Fair market, including products illegally imported into the country.

Prof. Adeyeye reaffirmed that NAFDAC will continue to take strict regulatory actions to protect Nigerians from unsafe drugs and counterfeit products. 

She urged the public to always check the registration status of medicines before purchase and report suspicious products to the nearest NAFDAC office.