ABUJA, Nigeria – The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a nationwide recall of a batch of Amoxivue (Amoxicillin) 500mg capsules after laboratory tests revealed the product contained dangerously low levels of the active pharmaceutical ingredient (API).
The affected medicine, bearing NAFDAC registration number A4-100178 and Batch No. 322584, was produced by Sparsh Bio-Tech Pvt. Ltd in October 2023 and set to expire in October 2026. It was found to contain only 26.3% of the stated amoxicillin content—far below the acceptable therapeutic threshold.
NAFDAC on Thursday disclosed the development in Public Alert No. 024/2025, describing the batch as “substandard and potentially harmful to public health.”
Samples were reportedly collected from a facility in Sokoto and two locations across local government areas in Plateau State. Laboratory analysis using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR) confirmed that the batch failed to meet both weight variation and infrared absorption spectrum specifications.
“The low API content compromises the product’s therapeutic efficacy, increasing the risk of treatment failure and antibiotic resistance,” the agency warned.
Amoxivue is commonly prescribed to treat a range of bacterial infections including respiratory tract infections, sinusitis, ear infections, UTIs, and skin infections. As a penicillin-based antibiotic, its efficacy depends heavily on correct dosage levels.
NAFDAC has instructed its zonal directors and state coordinators to “intensify surveillance and carry out immediate mop-up of the affected products from circulation.”
The regulatory body also urged healthcare professionals, retailers, and caregivers to remain vigilant. “Only obtain medical products from licensed suppliers,” the agency stated. “Check for authenticity and physical integrity before administration or sale.”
Members of the public are advised to report any suspicious medicines or side effects through NAFDAC’s toll-free line 0800-162-3322, via email at sf.alert@nafdac.gov.ng, or through its Med-Safety mobile app and E-reporting platforms available on the NAFDAC website.
