The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a detailed clarification to help Nigerians better understand its recent publication listing 101 drugs that have been withdrawn, suspended, or cancelled by the agency.
The agency said the clarification was necessary to provide transparency about the regulatory status of the affected products and to protect public health.
In a statement signed by Prof. Mojisola Adeyeye, NAFDAC’s Director-General, the agency explained the meanings and implications of each classification — withdrawn, suspended, and cancelled.
Explanation of Classifications
According to NAFDAC:
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Withdrawn products are those voluntarily discontinued by their manufacturers, usually for commercial or market reasons rather than safety or quality concerns.
Examples include Artemether/Lumefantrine 40mg/240mg tablets by Healthline Limited and ASAQ (Artesunate Amodiaquine Winthrop) by Sanofi Aventis Nigeria Ltd, both voluntarily withdrawn for business reasons. -
Suspended products are those temporarily halted by NAFDAC due to non-compliance with regulatory standards. Their registration remains under review until the manufacturer corrects the identified lapses.
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Cancelled products have had their registration permanently revoked, meaning they are no longer approved for manufacture, importation, sale, or use in Nigeria. Cancellations typically arise from issues such as safety risks, poor manufacturing practices, or failed quality control tests.
Prof. Adeyeye noted that publishing such lists is a global best practice aimed at preventing counterfeit circulation and ensuring unsafe or discontinued medicines do not remain in the market.
Notable Affected Products
Some of the well-known medicines on the list include:
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Flagyl Suspension and Tablets (400mg) – now delisted, though other Metronidazole formulations remain registered.
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Januvia (50mg & 100mg), Janumet (50mg/850mg), and Amaryl M Tablets (1mg–4mg SR) – all withdrawn from the market.
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Aprovasc (150mg/5mg), Coaprovel (300mg/25mg), and Abacavir Sulfate/Lamivudine (60mg/30mg) – among other cardiovascular and antiretroviral products removed.
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Penicillin G Sodium Sandoz Powder (1,000,000 IU) – voluntarily withdrawn by Novartis Nigeria Ltd.
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Elisa Eye Drops (Chloramphenicol) – approval revoked for regulatory violations.
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Norditropin Growth Hormone and certain Insulin Injectables – delisted after regulatory reviews.
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Cryomarex Rispens HVT Vaccine – removed due to regulatory action.
NAFDAC advised consumers and healthcare professionals to verify product registration status through its official website or regional offices before purchase or use.
Ongoing Crackdown on Counterfeit Drugs
The agency reiterated its commitment to public safety, citing recent enforcement operations across the country.
In October 2025, NAFDAC destroyed counterfeit, expired, controlled, and banned drugs worth over ₦15 billion in Ibadan, Oyo State, including Analgin, Co-codamol, Tramadol, Oxytocin, and fake vaccines.
A month earlier, it uncovered a ₦1.2 billion warehouse of unregistered Malamal Forte malaria drugs in Ilasa-Oshodi, Lagos, concealed in cartons falsely labelled as Diclofenac Potassium.
At Lagos Trade Fair Market, officials also confiscated banned and unregistered cosmetics worth over ₦1.5 billion, while a truckload of fake goods was intercepted before reaching distribution points.
NAFDAC reaffirmed that its surveillance and enforcement teams would continue nationwide operations to eliminate substandard and falsified products from circulation.
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