By Precious Mark
The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over a voluntary recall of Sporidex Suspension 125 mg/5 ml, a popular antibiotic commonly prescribed for children, due to safety concerns.
The warning was disclosed in Public Alert No. 033/2026, issued on Friday by the regulatory agency.
According to NAFDAC, the Marketing Authorization Holder, Ranbaxy Nigeria Ltd (a Sun Pharma Company), initiated the recall as a precautionary measure after detecting an impurity that exceeded approved specification limits during routine testing.
The agency warned that the elevated impurity compromises the quality, safety, and stability of the product; specifically batch number DFG4606A; which could lead to severe health risks in pediatric patients.
“Potential risks associated with the use of the affected product include reduced antibiotic effectiveness, which may result in incomplete bacterial eradication, delayed recovery, worsening infection, or treatment failure,” NAFDAC stated.
Adding that it could also fuel antimicrobial resistance or trigger adverse reactions such as nausea, vomiting, diarrhea, stomach discomfort, and skin rashes.
NAFDAC has directed all zonal directors and state coordinators to commence nationwide surveillance and mop-up operations to sweep the affected batch from markets, pharmacies, and hospitals across the country.
Healthcare providers, distributors, retailers, and caregivers have been urged to immediately stop the sale, distribution, or administration of the specific batch, quarantine existing stock, and report any adverse reactions through NAFDAC’s e-reporting platforms or the nearest office.