NAFDAC Recalls Substandard Amoxivue (Amoxicillin) 500mg Capsules

The affected product, with NAFDAC Registration Number A4-100178 and Batch Number 322584, was manufactured in October 2023 by Sparsh Bio-Tech Pvt. Ltd. and is set to expire in October 2026.

Samples collected from one facility in Sokoto State and two others in different Local Government Areas in Plateau State were tested using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR). The results revealed an alarmingly low API content of just 26.3%, far below acceptable therapeutic levels.

Additionally, the product failed critical quality tests, including weight variation and infrared absorption spectrum, leading NAFDAC to conclude that the drug is substandard and poses serious public health risks.

Amoxivue (Amoxicillin) is a commonly prescribed antibiotic for treating a range of bacterial infections, including those of the respiratory tract, ears, sinuses, urinary tract, and skin. The significantly low amoxicillin content could lead to therapeutic failure, antibiotic resistance, complications from untreated infections, and misleading clinical outcomes.

NAFDAC urged all healthcare professionals and consumers to immediately cease the distribution and use of the affected batch. Suspected cases of substandard or falsified medicines should be reported to the nearest NAFDAC office, via the toll-free number 0800-162-3322, or through email at sf.alert@nafdac.gov.ng.

For more information, visit NAFDAC Alert No. 024/2025.