Pharmaceutical Product Recalls in Kenya (2016 to 2025): Trends in Quality Defects, Therapeutic Class Patterns, Manufacturing Gaps, and Regulatory Insights

This retrospective study analyzes 171 pharmaceutical product recalls issued by the Pharmacy and Poisons Board (PPB) in Kenya between January 2016 and November 2025 to characterize patterns in medicine quality defects, therapeutic classes affected, manufacturing gaps, and regulatory implications. Recall notices were extracted from the PPB database and coded by year, therapeutic category, dosage form, product origin, and stated reason for recall. Of the 171 recalled products, 148 (86.5%) were due to quality-related defects, with physical and organoleptic abnormalities such as discoloration, spotting, molding, and tablet breakage representing 63 (36.8%) recalls, the largest single defect sub-category. Chemical and assay failures were observed in 34 (19.9%) recalls whereas 24 (14.0%) recalls were due to performance defects affecting dissolution, uniformity, and hardness. Anti-infectives particularly antibacterials and nervous-system products especially analgesics accounted for 52 (30.4%) and 37 (21.6%) of the recalled drug classes respectively, reflecting both their high market volume and vulnerability to quality test failures. Imported products accounted for 91 (53.0%) recalls, while locally manufactured products were 80 (47.0%). The observed upward trend in recall frequency is likely attributable to strengthened post-market surveillance rather than a true decline in product quality. The findings highlight recurrent manufacturing and stability gaps and challenges, including inadequate in-process controls, insufficient supplier qualification, weak stability testing for WHO Climatic Zone IVb conditions, and suboptimal packaging and distribution practices. To address these gaps, the study recommends enhanced quality assurance frameworks enhanced by current GMP and quality management systems among manufacturers, expanded post-market surveillance and pharmacovigilance programs by regulators, strict enforcement of climate-appropriate stability and packaging requirements, and adoption of digital track-and-trace systems. Strengthened regulatory stringency, transparency and surveillance are essential to mitigating the circulation of substandard and falsified medicines and safeguarding public health in Kenya.