The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the immediate withdrawal, suspension, or cancellation of 101 pharmaceutical products in Nigeria. The action takes effect immediately, and the affected products are no longer allowed for manufacture, importation, exportation, distribution, advertisement, sale, or use in the country.
According to NAFDAC, the removal of these products is grounded in regulatory checks and post-market surveillance, ensuring that only medicines meeting approved standards of quality, safety, and efficacy remain in circulation. The certificate of registration for each product is either withdrawn (voluntarily by the market authorization holder), suspended (if regulatory conditions are no longer met), or cancelled (revoked by NAFDAC) depending on the specific circumstances.
NAFDAC has called on healthcare providers, pharmacies, distributors, and the public to immediately discontinue use of the listed products and to report any adverse events or illegal trade relating to them.
Why This Matters: NAFDAC’s Regulatory Role & Precedents
Mandate & Authority
- NAFDAC is empowered by law to regulate drugs, food, cosmetics, chemicals, medical devices, and more in Nigeria.
- One of its core roles is post-market surveillance — even after a product is approved and in circulation, NAFDAC monitors safety, recalls, or takes regulatory action if a product is found to be substandard, counterfeit, unsafe, or noncompliant.
- The agency uses tools such as recalls, suspensions, withdrawals, or cancellations to enforce standards.
Past Recalls & Enforcement Patterns
- This is not the first time NAFDAC has withdrawn or recalled drugs, though the scale here (101 products) is unusually large.
- In previous years, individual medicines have been pulled following lab testing or reports of poor quality.
- The intensity of this action signals increased vigilance by NAFDAC, likely driven by public health concerns, pressure from consumers, or detection of irregularities in manufacturing, registration, or supply chains.
Implications for Stakeholders
- Patients & Consumers: Some people may still be using the drugs — those must be immediately discontinued and replaced with approved alternatives under medical supervision.
- Healthcare Professionals & Pharmacies: Must check inventories against the official list and ensure no further dispensing of the affected drugs.
- Manufacturers & Importers: The affected firms must comply with the withdrawal, may face penalties, and will need to revalidate quality, registration dossiers, or undergo inspections to regain approval.
- Regulatory & Public Trust: Such sweeping action may increase public confidence in regulatory oversight if effectively enforced, but also raise questions about how these products obtained registration in the first place.
Partial List of Affected Products & Classes
Below is a selection (not the full 101) of products that have been withdrawn, suspended, or cancelled:
| # | Product Name & Dosage / Form | Action / Notes |
|---|---|---|
| Abacavir Sulfate / Lamivudine Dispersible Tablets 60mg / 30mg | Withdrawn voluntarily by market authorization holder | |
| Amaryl M Tablets & Amaryl M SR (Glimepiride + Metformin) | Withdrawn voluntarily | |
| Aprovasc 150mg / 5mg Tablets | Withdrawn | |
| Artemether / Lumefantrine 40mg / 240mg Tablets | Withdrawn | |
| ASAQ (Artesunate + Amodiaquine Winthrop) in various strengths | Withdrawn | |
| Betopic Eye Drop | Withdrawn | |
| Coaprovel 300mg / 25mg Tablets | Withdrawn | |
| Efavirenz 600mg Tablets | Withdrawn | |
| Flagyl Suspension (and also Flagyl 400 mg Tablets) | Withdrawn | |
| Iliadin Adult 0.05% Metered Nose Spray | Withdrawn | |
| Invanz 1g Injections | Withdrawn | |
| Invega (Paliperidone) extended release tablets (3mg, etc.) | Withdrawn | |
| Janumet (Sitagliptin + Metformin) in various strengths | Withdrawn | |
| Januvia (Sitagliptin) in 50mg, 100mg | Withdrawn | |
| Kombiglyze (Saxagliptin + Metformin) | Withdrawn | |
| Lamivudine / Nevirapine / Zidovudine Dispersible Tablets (various strengths) | Withdrawn | |
| Lexotan 3mg (Bromazepam) | Withdrawn | |
| Mosegor Syrup, Mosegor Tablets (Pizotifen) | Withdrawn | |
| Nevirapine 200mg Tablets | Withdrawn | |
| Onglyza 2.5mg, 5mg (Saxagliptin) | Withdrawn | |
| Penicillin G Sodium (Powder for injection) | Withdrawn | |
| Salbutamol 100 µg Inhaler | Withdrawn | |
| Sporanox (Itraconazole) 100mg Capsule | Withdrawn | |
| Xyzal Oral Drops (Levocetirizine) | Withdrawn | |
| Zidovudine 300mg Tablets | Withdrawn | |
| Uptivite Man Tablets | Cancelled by NAFDAC | |
| Mist Alba Suspension | Cancelled by NAFDAC | |
| Gentle Hill Cough Syrup | Cancelled by NAFDAC | |
| Gentlehills Vitamin C Syrup | Cancelled by NAFDAC | |
| Mycobutin 150mg capsules | Withdrawn | |
| Neo-Medrol Lotion | Withdrawn | |
| Fortum Injection (Ceftazidime 1g) | Withdrawn | |
| Proximexa Injection (Cefuroxime Axetil 500mg) | Withdrawn | |
| Diclo-Neurobion Tablets (Diclofenac + B Vitamins) | Withdrawn | |
| Artemether / Lumefantrine 80 / 480 Tablets | Withdrawn | |
| Norditropin / Nordiflex (Somatropin) | Withdrawn | |
| Saxenda (Liraglutide) | Withdrawn | |
| Letrozole 2.5mg Tablets | Withdrawn | |
| Zometa (Intravenous infusion of Zoledronic Acid) | Withdrawn | |
| Valsartan (50mg, 80mg, 160mg Tablets) | Withdrawn | |
| Prezista (Darunavir) 75mg, 150mg, 600mg Tablets | Withdrawn | |
| Intelence (Etravirine) 25mg, 100mg Tablets | Withdrawn | |
| Daktarin 2% Cream (Miconazole) | Withdrawn | |
| Coveram (Perindopril + Amlodipine combinations) | Withdrawn | |
| Coversyl (Perindopril) 5mg, 10mg | Withdrawn | |
| Various “Plus” combinations (e.g. Coversyl plus, Coveram plus) | Withdrawn | |
| Natrilix SR 1.5mg (Indapamide SR) | Withdrawn | |
| Vastarel MR 60mg (Trimetazidine) | Withdrawn | |
| Diamicron MR 30mg, 60mg (Gliclazide MR) | Withdrawn | |
| Triveram (Atorvastatin / Perindopril / Amlodipine combinations) | Withdrawn | |
| Viacoram 3.5mg / 2.5mg, 7mg / 5mg | Withdrawn | |
| Natrixam (Indapamide / Amlodipine) | Withdrawn | |
| Braftovi 50mg, 75mg (Encorafenib) | Withdrawn | |
| Mektovi 15mg (Binimetinib) | Withdrawn |
What Patients, Health Workers, and Pharmacies Must Do
- Immediate Discontinuation & Switch
Patients currently using any of the listed drugs should cease use under proper medical supervision and be switched to alternative approved therapies. - Inventory Audit & Removal
Pharmacies, hospitals, clinics, and distributors must audit stocks, segregate the products, and remove them from sale. - Public Awareness & Reporting
Citizens should report any continued sale or use of the delisted items to NAFDAC. - Regulatory Compliance & Reapplication
Manufacturers and importers of affected products must review their records and may need to reapply or undergo inspections to regain approval.
Conclusion
NAFDAC’s bold action in withdrawing 101 pharmaceutical products underlines the agency’s renewed vigilance in protecting public health. While disruptive in the short term, this step is necessary to ensure Nigerians have access only to safe and effective medicines. The real test lies in implementation — ensuring these drugs are actually removed from circulation and that patients receive safe alternatives without interruption in their treatment.
