The National Agency for Food and Drug Administration and Control (NAFDAC)(NAFDAC) has announced a recall of Embacef 125 Powder for Oral Suspension, prompted by safety issues reported by users.
The recall targets products produced by Laborate Pharmaceutical India and distributed in Nigeria by Embassy Pharmaceutical and Chemicals Limited, based in Lagos.
In a public advisory (No. 029/2025) released on its website on Sunday, NAFDAC indicated that the recall was initiated following a complaint lodged at its Ekiti State office. The complaint highlighted that two bottles of the reconstituted suspension had solidified within two days of being opened.
Following an investigation, NAFDAC confirmed that the product did not meet quality standards and posed potential safety risks. The agency stated, “As a precautionary measure, the recall of the affected batch and any other batches showing similar issues has been mandated.”
Embacef 125 contains Cefuroxime Axetil, an antibiotic prescribed for a variety of bacterial infections, including bronchitis, gonorrhea, Lyme disease, as well as skin, ear, sinus, throat, tonsil, and urinary tract infections. The specific details of the recalled product include a manufacturing date of February 2025, an expiry date of January 2027, and batch number PEDSE001, with NAFDAC Registration Number (NRN) A4-9040.
NAFDAC cautioned that the use of substandard antibiotics may exacerbate health problems, result in treatment failures, and contribute to the development of antibiotic-resistant bacteria.
The agency has instructed zonal directors and state coordinators to enhance surveillance efforts and ensure the removal of the affected product from the market.
NAFDAC urged importers, distributors, retailers, healthcare professionals, and patients to remain alert and procure medications exclusively from authorized and licensed sources.
It further emphasized the importance of verifying product authenticity and physical condition. Healthcare professionals and consumers are encouraged to report any suspected substandard or counterfeit medications to the nearest NAFDAC office, via the hotline 0800-162-3322, or through email at sf.alert@nafdac.gov.ng. Reports regarding adverse events or side effects associated with this product can also be filed using the Med-Safety App (available on both Android and iOS), through NAFDAC’s e-reporting platforms at www.nafdac.gov.ng, or via email at pharmacovigilance@nafdac.gov.ng.
Additionally, NAFDAC announced that this notification will be shared with the World Health Organisation’s Global Surveillance and Monitoring System (GSMS) to aid in international tracking and intervention efforts.
(NAN)
