The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the voluntary recall of a specific batch of Sporidex Suspension 125 mg/5 mL after an impurity exceeding the approved specification limit was detected, raising concerns over the medicine's quality, safety, and stability.
In Public Alert No. 033/2026, the agency said the recall affects Batch No. DFG4606A and was initiated by the product's Marketing Authorisation Holder, Ranbaxy Nigeria Ltd., a Sun Pharma Company, as a precautionary measure.
NAFDAC advised healthcare professionals, distributors, pharmacies, hospitals, and the public to stop using, distributing, or selling the affected batch while the recall process is ongoing.
in \june the agency had reported that the impurity detected in the product could reduce the effectiveness of the antibiotic, leading to incomplete elimination of bacterial infections, delayed recovery, worsening illness, or treatment failure. The agency also warned that continued use of the affected batch could contribute to the growing challenge of antimicrobial resistance.
The report also highlighted that patients may experience an increased risk of adverse reactions, including nausea, vomiting, diarrhoea, stomach discomfort, and skin rash.
Sporidex Suspension 125 mg/5 mL is a cephalosporin antibiotic containing cephalexin and is commonly prescribed for children to treat bacterial infections affecting the throat, ears, skin, bones, teeth, urinary bladder, and kidneys.
NAFDAC disclosed that all zonal directors and state coordinators have been directed to carry out surveillance and mop-up operations to identify and remove the affected batch from circulation across the country.
The agency further instructed distributors, wholesalers, retailers, pharmacies, hospitals, and other healthcare facilities to immediately cease the distribution and sale of the affected batch. Individuals and organisations in possession of the product have been advised to quarantine the medicine and discontinue further supply.
Consumers and caregivers who have the recalled batch were urged not to use the product and instead return it to the point of purchase or the nearest healthcare facility.
NAFDAC also encouraged healthcare professionals and patients to report any adverse reactions or side effects associated with medicinal products or medical devices through the nearest NAFDAC office, the agency's e-reporting platforms, the Med Safety App, or via email at pharmacovigilance@nafdac.gov.ng.
The agency said the recall forms part of its ongoing efforts to protect public health by ensuring that only medicines meeting approved quality, safety, and efficacy standards remain in circulation.
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