The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the withdrawal, suspension, and cancellation of 101 pharmaceutical products across the country, in a sweeping regulatory action aimed at safeguarding public health.
In a statement published on its official website, the agency said the affected products are no longer permitted for manufacture, importation, exportation, distribution, advertisement, sale, or use in Nigeria.
Why Products Are Delisted
NAFDAC explained that the removal of products from circulation falls into three regulatory categories:
- Withdrawal — When a product’s registration is discontinued voluntarily by the manufacturer or market authorisation holder.
- Suspension — When a product no longer meets the conditions under which its registration license was issued, pending further determination.
- Cancellation — When NAFDAC formally revokes the certificate of registration, permanently barring the product from circulation.
According to the agency, these measures are part of ongoing efforts to ensure that only safe, effective, and quality medicines remain accessible to Nigerians.
Sample of Products Affected
While the full list contains 101 products, below are some of those officially withdrawn:
| S/N | Product Name | Dosage Form | NAFDAC Number | Active Ingredient | Market Authorisation Holder | Application Purpose |
|---|---|---|---|---|---|---|
| 1 | Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg | Tablets | C4-1180 | Abacavir Sulfate + Lamivudine | Healthline Limited | Withdrawn voluntarily by Market Authorisation Holder |
| 2 | Amaryl M Tablets | Tablets | A4-2619 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria Ltd | Withdrawn voluntarily by Market Authorisation Holder |
| 3 | Amaryl M SR Tablets | Tablets | A4-7296 | Glimepiride + Metformin Hydrochloride | Sanofi Aventis Nigeria Ltd | Withdrawn voluntarily by Market Authorisation Holder |
| 4 | Aprovasc 150mg/5mg Tablets | Tablets | B4-2687 | Amlodipine Besylate + Aprovasc | Sanofi Aventis Nigeria Ltd | Withdrawn voluntarily by Market Authorisation Holder |
| 5 | Artemether/Lumefantrine 40mg/240mg Tablets | Tablets | B4-5745 | Artemether + Lumefantrine | Healthline Limited | Withdrawn voluntarily by Market Authorisation Holder |
| 6 | ASAQ (Artesunate Amodiaquine Winthrop) 100mg/270mg | Tablets | A4-3357 | Artesunate + Amodiaquine | Sanofi Aventis Nigeria Ltd | Withdrawn voluntarily by Market Authorisation Holder |
| 7 | ASAQ (Artesunate Amodiaquine Winthrop) 25mg/67.5mg | Tablets | A4-3406 | Artesunate + Amodiaquine | Sanofi Aventis Nigeria Ltd | Withdrawn voluntarily by Market Authorisation Holder |
The complete list of all affected 101 products is available on the NAFDAC website.
Implications for Consumers
Public health experts warn that patients and healthcare providers must immediately take note of the update to avoid using or prescribing the affected medicines.
“Once a product is delisted, it is no longer authorised for sale. Consumers must check packaging details, especially the NAFDAC number, to ensure the product they are buying is still valid,” said a Lagos-based pharmacist, who urged hospitals and pharmacies to cross-check their stock.
Withdrawal does not always mean a product is unsafe; in many cases, it may be a business decision by the manufacturer. However, suspension or cancellation often points to compliance or quality concerns, requiring consumers to exercise caution.
Broader Regulatory Efforts
The move comes as part of NAFDAC’s intensified regulatory drive to clamp down on substandard, falsified, and unsafe medicines in Nigeria’s pharmaceutical market.
The agency has recently carried out raids on unregistered drugs, tightened monitoring of imported medicines, and increased inspections of local manufacturers.
Commissioner for Health experts stress that such actions are crucial in a country where counterfeit drugs remain a public health threat.
Voices from the Public
Patients and traders have reacted with mixed feelings. Some welcome the action as necessary for consumer protection, while others worry about the availability of affordable alternatives.
“This is a bold step by NAFDAC. But we also hope that replacement medicines will be available at reasonable prices so that patients don’t suffer,” said Chika Okafor, a community pharmacist in Abuja.
Top 5 Widely Used Drugs Affected
Among the withdrawn products are several medicines widely used by Nigerians:
- Amaryl M / Amaryl M SR (Glimepiride + Metformin Hydrochloride) – Popularly prescribed for type 2 diabetes management.
- Aprovasc (Amlodipine + Valsartan) – A common blood pressure medication.
- Artemether/Lumefantrine Tablets – Widely used as first-line treatment for malaria.
- ASAQ (Artesunate + Amodiaquine Winthrop) – Another major malaria treatment drug.
- Abacavir Sulfate/Lamivudine Tablets – Key component in antiretroviral therapy for HIV patients.
Their withdrawal is expected to draw close attention from healthcare providers and patients who depend on them for treatment.
✅ What Nigerians Should Do
- Check labels: Always verify NAFDAC numbers and confirm whether a product is still authorised.
- Consult professionals: Patients currently on any of the affected drugs should speak with their doctors or pharmacists for safer alternatives.
- Stay informed: Follow NAFDAC’s official updates for the latest product advisories.
With this latest move, NAFDAC has sent a strong signal that it will continue to enforce compliance with safety standards, ensuring that only products meeting the highest quality requirements remain on Nigerian shelves.