NAFDAC orders nationwide recall of all Europharm products over safety failures

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a nationwide mop-up of all pharmaceutical and regulated products produced and distributed by Europharm Laboratories after an investigation uncovered widespread violations and serious quality defects.

According to the agency, enforcement actions commenced following credible intelligence and routine surveillance, which revealed that Europharm Laboratories had been manufacturing, selling, and distributing multiple products without the required marketing authorisation.

During the investigation, NAFDAC operatives discovered several products at the company’s Jos facility that were being produced or circulated in breach of regulatory standards. Laboratory analyses conducted on selected samples confirmed significant quality failures, raising what the agency described as grave public health concerns.

Two key products—Linmoxyn (Amoxicillin) suspension and Linmoxyn (Amoxicillin 500mg capsules)—failed laboratory tests with active pharmaceutical ingredient (API) levels far below acceptable limits. The suspension recorded API contents of 13.9 percent and 18.4 percent, while the capsules contained just 48.3 percent, rendering both medicines grossly substandard and potentially harmful.

A total of 17 products, all bearing various NAFDAC Registration Numbers, were found at the Europharm facility. They include:

1. Linocloxin (Ampicillin 125mg & Cloxacillin 125mg) suspension – NRN 04-4576

2. Linromycine (Erythromycin) suspension – NRN 04-4573

3. Linocillin (Ampicillin) suspension – NRN 04-4560

4. Linmoxyn (Amoxicillin 125mg) suspension – NRN 04-4567

5. Eurogyl (Metronidazole) suspension – NRN 04-4568

6. Naflin (Cough Expectorant) – NRN 04-4558

7. Natacid (Magnesium Trisilicate) suspension – NRN 04-5752

8. Navit-B Syrup (Vitamin B Complex) – NRN 04-4572

9. Fountain B-12 (Blood Tonic) 100ml – NRN 04-4569

10. Fountain B-12 (Blood Tonic) 200ml – NRN 04-4569

11. Vitamin-C Syrup – NRN 04-5001

12. Eurogyl (Metronidazole) tablets (blister) – NRN 04-4563

13. Eurogyl (Metronidazole) tablets (bulk) – NRN 04-4563

14. Euramol (Paracetamol) tablets – NRN 04-4564

15. Euramox (Mebendazole 100mg) tablets – NRN 04-4566

16. Linotrim (Cotrimoxazole) suspension – NRN 04-4574

17. Linoquine (Chloroquine Phosphate 80mg/5ml) syrup – NRN 04-4571

NAFDAC urged distributors, retailers, healthcare providers, and caregivers to exercise heightened vigilance across the supply chain to prevent further circulation of the implicated products. The agency advised that all medical products must be sourced from authorised suppliers and checked for authenticity and proper physical condition.

Members of the public and health professionals were encouraged to report suspected cases of substandard or falsified medicines to the nearest NAFDAC office, via the toll-free line 0800-162-3322, or by email to sf.alert@nafdac.gov.ng