NAFDAC Orders Nationwide Recall of Children’s Antibiotic Over Safety Concerns

By George Omagbemi Sylvester

The National Agency for Food and Drug Administration and Control (NAFDAC) has ordered the nationwide recall of a batch of Sporidex Suspension 125 mg/5 mL, a commonly prescribed antibiotic for children, after an impurity exceeding approved safety limits was detected during routine quality checks. The agency warned that the affected product could pose potential health risks and urged the public to stop using it immediately.

According to NAFDAC, the voluntary recall was initiated by Ranbaxy Nigeria Ltd., a Sun Pharma company, the marketing authorisation holder for the medicine.

The recall affects Batch Number DFG4606A of Sporidex Suspension, which contains cephalexin, an antibiotic widely used to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary bladder and kidneys in children.

The agency explained that the detected impurity may compromise the medicine’s quality, safety and stability, potentially reducing its effectiveness.

NAFDAC warned that continued use of the affected batch could lead to incomplete elimination of bacteria, delayed recovery, worsening infections, treatment failure and an increased risk of antimicrobial resistance. Possible adverse reactions include nausea, vomiting, diarrhoea, stomach discomfort and skin rashes.

NAFDAC has directed all distributors, wholesalers, retailers, pharmacies, hospitals and healthcare providers to immediately stop the distribution and sale of the affected batch. Consumers and caregivers who have the recalled product have been advised not to administer it to children but to return it to the point of purchase or the nearest healthcare facility.

The agency has also instructed its zonal directors and state coordinators to commence surveillance and nationwide mop-up operations to remove the product from circulation.

The regulatory agency further urged healthcare professionals and members of the public to report any adverse reactions associated with the medicine through NAFDAC’s pharmacovigilance reporting channels.

It reiterated its commitment to safeguarding public health by ensuring that only medicines meeting approved quality, safety and efficacy standards remain available in the Nigerian market.