When it comes to drug development and manufacturing, impurities can pose very serious risks if undetected or improperly controlled within acceptable limits. Impurities and contaminants discovered during manufacturing can delay product approvals and batch release. Impurities detected in drug products already on consumer shelves can trigger drug recalls and prompt regulatory actions. In a recently released analysis of US FDA reported drug recall data (2012-2023), the most frequent cause of recalls was found to be impurities and contaminants.1
1 Seppe Ghijs et al, “The continuing challenge of drug recalls: Insights from a ten-year FDA data analysis,” Journal of Pharmaceutical and Biomedical Analysis, Oct 2024
