National Agency for Food and Drug Administration and Control (NAFDAC) has issued a recall notice for the antibiotic product Embacef 125 Powder for Oral Suspension, following safety complaints received from consumers.
The recalled product, manufactured by Laborate Pharmaceutical India and registered in Nigeria by Embassy Pharmaceutical and Chemicals Ltd, Lagos, was reported to have caked or solidified after reconstitution by the second day of use. This complaint was brought to NAFDAC’s attention at its Ekiti State office, prompting a thorough investigation.
NAFDAC’s findings confirmed the product’s substandard quality and potential health risks associated with its use. As a precautionary measure, the agency has mandated a recall of the affected batch, identified by batch number PEDSE001, manufactured in February 2025 and expiring in January 2027.
Embacef 125 contains Cefuroxime Axetil, an antibiotic used to treat a variety of bacterial infections such as bronchitis, gonorrhea, Lyme disease, and infections of the skin, ears, sinuses, throat, tonsils, and urinary tract.
The agency warned that using substandard antibiotics could worsen patient conditions, lead to treatment failures, and contribute to the emergence of antibiotic-resistant bacteria.
NAFDAC has directed all zonal directors and state coordinators to intensify surveillance activities and remove the affected products from circulation. The public has been urged to purchase medicines only from authorized and licensed suppliers and to verify product authenticity and physical condition before use.
Consumers and healthcare professionals are encouraged to report any suspected cases of substandard medicines or adverse effects via NAFDAC’s hotline, email, or the Med-Safety App.
The recall notification has also been shared internationally through the World Health Organisation’s Global Surveillance and Monitoring System to enhance global tracking and intervention efforts.
This swift action by NAFDAC underscores the agency’s commitment to safeguarding public health and ensuring the availability of safe, effective medicines in Nigeria.
