The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a recall alert for Embacef 125 Powder for Oral Suspension, citing serious quality and safety concerns.
The affected product was manufactured by Laborate Pharmaceutical India and registered in Nigeria by Embassy Pharmaceutical and Chemicals Ltd, Lagos.
In a Public Alert No. 029/2025 released on Sunday via its official website, NAFDAC said the recall was prompted by a complaint lodged at its Ekiti State office, where it was reported that two bottles of the reconstituted antibiotic had solidified by the second day of use.
Following an investigation, NAFDAC confirmed that the product was substandard and posed potential health risks. As a precaution, the agency has ordered a recall of the affected batch number PEDSE001, as well as any other batches showing similar issues.
Product Details:
Product name: Embacef 125 Powder for Oral Suspension
Active ingredient: Cefuroxime Axetil
Batch number: PEDSE001
Manufacturing date: February 2025
Expiry date: January 2027
NAFDAC Registration Number: A4-9040
Cefuroxime Axetil is a commonly used antibiotic for treating bacterial infections such as bronchitis, gonorrhea, Lyme disease, and infections of the skin, ears, sinuses, throat, tonsils, and urinary tract.
NAFDAC warned that using substandard antibiotics like this could lead to treatment failure, worsen patients’ conditions, and contribute to the growing threat of antibiotic resistance.
The agency has instructed all zonal directors and state coordinators to intensify market surveillance and ensure the immediate removal of the affected products from circulation.
NAFDAC urged importers, distributors, retailers, healthcare providers, and the general public to exercise caution and ensure all medicines are sourced from authorized and licensed suppliers.
Healthcare professionals and consumers are encouraged to report any suspected substandard or falsified medicines to the nearest NAFDAC office, or via: Toll-Free Number: 0800-162-3322
Email: sf.alert@nafdac.gov.ng
Adverse event reporting: Use the Med-Safety App (available on Android and iOS), or submit reports via www.nafdac.gov.ng or pharmacovigilance@nafdac.gov.ng
NAFDAC also stated that this alert would be shared with the World Health Organization’s Global Surveillance and Monitoring System (GSMS) to aid international tracking and action.
Credit: Vanguard
