20/08/2025
Public Safety Notice – Amoxivue (Amoxicillin) 500mg Recall
The National Agency for Food and Drug Administration and Control (NAFDAC) is warning the public about the recall of a specific batch of Amoxivue (Amoxicillin) 500mg capsules. The affected product carries NAFDAC Registration Number A4-100178, Batch Number 322584, and was produced by Sparsh Bio-Tech Pvt. Ltd.
This batch, manufactured in October 2023 with an expiry date of October 2026, was taken from a facility in Sokoto and two facilities in Plateau State for quality testing. Laboratory analysis using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR) revealed that the capsules contained only 26.3% of the expected Active Pharmaceutical Ingredient (API).
Further checks showed that both the weight variation and infrared absorption spectrum failed to meet required standards. These findings confirm that the medicine is substandard, prompting its removal from circulation.
Amoxivue (Amoxicillin) is a penicillin-based antibiotic commonly prescribed for bacterial infections such as chest infections, ear and sinus infections, urinary tract infections, and certain skin infections. A reduced API level means patients could face treatment failure, higher risk of complications, possible antibiotic resistance, and misleading clinical evaluations.
Members of the public and healthcare providers should immediately stop using this batch and report any suspected cases of substandard or falsified medicines to the nearest NAFDAC office. You can also call 0800-162-3322 or email sf.alert@nafdac.gov.ng to make a report.
NAFDAC NIGERIA
