NAFDAC Withdraws, Suspends, or Cancels 101 Pharmaceutical Products in Nigeria

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the immediate withdrawal, suspension, or cancellation of 101 pharmaceutical products from the Nigerian market. Effective immediately, the affected medicines are banned from manufacture, importation, exportation, distribution, advertisement, sale, or use across the country.

According to NAFDAC, this sweeping regulatory action follows extensive post-market surveillance and regulatory checks designed to protect public health. The agency emphasized that only products meeting approved standards of safety, quality, and efficacy would be permitted to remain in circulation.

Each of the 101 products falls into one of three regulatory categories: withdrawn (voluntarily removed by the market authorization holder), suspended (temporarily disallowed due to unmet regulatory conditions), or cancelled (revoked outright by NAFDAC).

Healthcare providers, pharmacies, distributors, and the general public have been directed to immediately stop the use or sale of the listed medicines. Citizens are also encouraged to report any continued circulation, adverse events, or illegal trade involving the affected drugs.

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Why This Matters: NAFDAC’s Mandate and Role

NAFDAC is the national regulatory authority responsible for overseeing drugs, food, cosmetics, chemicals, medical devices, and related products in Nigeria. Its mandate includes ensuring that only safe, effective, and high-quality products are accessible to Nigerians.

A key tool in this process is post-market surveillance, where products already in circulation are continuously monitored for compliance. Even after a drug is initially approved, NAFDAC retains the authority to intervene if concerns arise about safety, substandard quality, falsification, or regulatory noncompliance.

This is not the first time NAFDAC has recalled or suspended medicines, but the scale of the present action—101 products at once—marks one of the largest regulatory interventions in recent years. It highlights a heightened vigilance by the agency, possibly spurred by public health risks, consumer complaints, or irregularities in manufacturing and importation processes.

Implications for Stakeholders

For Patients and Consumers: Individuals currently using any of the withdrawn products must discontinue immediately under medical supervision and transition to safe alternatives. Continuing to use unapproved drugs could pose health risks, especially where efficacy or dosage reliability is in question.

For Healthcare Providers and Pharmacies: Hospitals, pharmacies, and distributors are required to audit their inventory, identify affected products, and remove them from stock. Dispensing any of the listed drugs is now illegal and could attract regulatory penalties.

For Manufacturers and Importers: The companies whose products are affected must comply with the withdrawal and may need to revalidate their dossiers, undergo inspections, or face sanctions before regaining approval. This action signals stricter enforcement of compliance going forward.

For the Public and Regulators: While disruptive in the short term, such decisive enforcement strengthens public trust in Nigeria’s drug regulatory system. However, it also raises important questions about how these products were initially registered and how oversight mechanisms might be tightened to prevent recurrence.

Examples of Affected Products

Although the full list contains 101 products, notable withdrawals include antimalarials, antibiotics, antivirals, cardiovascular medicines, diabetic treatments, psychiatric drugs, and other commonly used therapies.

• Antimalarials: Artemether/Lumefantrine combinations, ASAQ (Artesunate + Amodiaquine), and Artesunate-based dispersible tablets.
• Antiretrovirals: Abacavir/Lamivudine, Lamivudine/Nevirapine/Zidovudine, Efavirenz, Nevirapine, Zidovudine.
• Diabetes Treatments: Amaryl M, Janumet, Januvia, Kombiglyze, Onglyza, Diamicron MR.
• Cardiovascular Drugs: Coaprovel, Aprovasc, Valsartan (various strengths), Coversyl and Coveram (Perindopril combinations), Natrilix SR, Vastarel MR, Triveram, Viacoram, Natrixam.
• Other Withdrawn Medicines: Flagyl suspension and tablets, Betopic eye drops, Invanz injections, Invega (Paliperidone), Lexotan (Bromazepam), Mosegor syrup and tablets, Penicillin G sodium, Salbutamol inhalers, Sporanox (Itraconazole), Mycobutin, Fortum (Ceftazidime), Proximexa (Cefuroxime), Daktarin cream, Saxenda, Letrozole, Zometa infusion, Prezista, Intelence, Braftovi, and Mektovi.

In addition to withdrawals, a smaller number of products were cancelled outright by NAFDAC, including:

• Uptivite Man Tablets
• Mist Alba Suspension
• Gentle Hill Cough Syrup
• Gentlehills Vitamin C Syrup

These cancellations mean the products are permanently banned and cannot re-enter the Nigerian market under their current formulations or approvals.

What Patients, Health Workers, and Pharmacies Must Do

1. Immediate Discontinuation: Patients using any of the listed medicines should stop immediately under the guidance of healthcare professionals to avoid disruption in treatment or health risks. Safe alternatives should be prescribed by doctors.
2. Inventory Audits: Pharmacies, clinics, and distributors must conduct urgent stock reviews to identify and isolate the affected products, ensuring they are not dispensed to the public.
3. Public Reporting: Consumers are encouraged to report sightings of delisted drugs in circulation, as well as any adverse reactions experienced from their use, to NAFDAC via its official hotlines and reporting platforms.
4. Regulatory Compliance: Manufacturers and importers must comply with NAFDAC’s orders and may need to undergo fresh inspections, provide updated quality evidence, or face penalties if found complicit in breaches.

Broader Impact and Public Confidence

While the withdrawal of 101 products may cause short-term disruptions for patients and providers, it underscores NAFDAC’s renewed commitment to safeguarding public health. Such decisive action not only reinforces the agency’s regulatory authority but also serves as a warning to manufacturers and distributors that Nigeria will not compromise on safety and quality.

At the same time, this intervention raises critical questions: How did so many products, including globally recognized medicines, pass through initial approvals only to be withdrawn later? Strengthening surveillance, improving testing facilities, and enhancing international cooperation will be key to ensuring that substandard or noncompliant medicines do not slip into circulation again.

NAFDAC’s bold move to withdraw, suspend, or cancel 101 pharmaceutical products sends a strong signal that Nigeria’s regulatory system is becoming stricter and more responsive to public health concerns. While patients, healthcare workers, and distributors must now adjust quickly, the long-term benefit lies in ensuring that only safe, effective, and high-quality medicines are available in Nigeria.

The true test will be in enforcement—making sure the products are completely removed from shelves and that Nigerians have access to reliable alternatives without interruption. If successfully executed, this unprecedented action could mark a turning point in Nigeria’s drug regulation landscape, strengthening both local confidence and international credibility in its healthcare system.