Investigating pharmaceutical product recalls due to discolouration: a Kenyan case review (January 2016–December 2024)

Abstract

Product discolouration is a visually detectable quality defect that can undermine patient trust, often leading to non-adherence due to fears of contamination or chemical degradation. A retrospective study of product recalls due to discolouration, within Kenya, between January 2016 and December 2024 was conducted. Study data was extracted from the Pharmacy and Poisons Board online database, which forms a repository of all product recalls and rapid/safety alerts. All recall entries due to product discolouration were included in the study. A total of 36 products were recalled due to discolouration during the study period, with the number of recalls varying from none to 9 products per year. Tablets constituted 55.6% of the recalled products. A total of 38.9% of the products were anti-infectives. This is a notable concern, as abrupt disruption of anti-infective treatment and/or substandard products can drive drug resistance. Generic formulations comprised 97.2% of recalled products. Twenty-one industries were involved in the manufacture of recalled products, with six industries being affected by multiple recalls. Products locally manufactured in Kenya accounted for 63.9% of the recalls. A comprehensive discussion of the probable causes of the observed discolouration, guided by use of the fishbone (Ishikawa) diagram, revealed three sub-themes namely chemical reactions: microbiological and physical contamination. Product recalls due to discolouration proved to be an emerging concern, affecting up to 70 batches of a product in some cases. The in-depth discussion provides guidance on conducting investigations to identify the root cause of observed defects. The adoption of the fishbone tool alongside development of structured forms for defect reporting and quality assurance workflows is recommended.