NAFDAC Retrieves Substandard Batch of Amoxivue 500mg Capsules Over Safety Concerns

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Published by Rosemary Osuoha, B Pharm
Last updated on August 7, 2025
Public Health Risks | Regulatory Action and Public Advisory | What Patients and Healthcare Professionals Can Do

The National Agency for Food and Drug Administration and Control (NAFDAC) has announced the recall of a specific batch of Amoxivue (Amoxicillin) 500mg capsules due to quality issues that pose potential health risks to the public.

The affected batch, Batch No. 322584, with NAFDAC registration number A4-100178—was manufactured in October 2023 by Sparsh Bio-Tech Pvt. Ltd, based in Gujarat, India. The capsules, which have an expiry date of October 2026, were collected for routine testing from a facility in Sokoto State and two locations in Plateau State

Laboratory tests conducted using High-Performance Liquid Chromatography (HPLC) and Fourier Transform Infrared Spectroscopy (FTIR) revealed significant quality defect.

According to NAFDAC, the active pharmaceutical ingredient (API) content was only 26.3%, far below acceptable standards. In addition, the product failed the weight variation test and did not meet the expected infrared absorption spectrum. These findings confirm that the batch is substandard.

Amoxivue is an antibiotic used to treat various bacterial infections such as respiratory tract infections, urinary tract infections (UTIs), ear and sinus infections, and skin conditions. It contains amoxicillin, a penicillin-based antibiotic designed to stop the growth of bacteria

Public Health Risks

Using Amoxivue capsules with insufficient amoxicillin content may result in treatment failure, antibiotic resistance, worsening of infections and misleading clinical outcomes.

Regulatory Action and Public Advisory

In response, NAFDAC has directed all zonal directors and state coordinators to initiate surveillance and ensure the complete removal of the affected batch from circulation. Distributors, pharmacists, and healthcare workers are urged to:

  • Verify the source of medical products
  • Verify the source of medical products
  • Stop the distribution or sale of the affected batch immediately

What Patients and Healthcare Professionals Can Do

Patients and healthcare workers play a crucial role in reporting and responding to unsafe medicines. Here’s what you can do:

  • Avoid using Amoxivue 500mg capsules from Batch No. 322584.
  • Check product packaging for signs of tampering or poor quality.
  • Report any suspect vials or adverse reactions immediately to regulatory authorities via: