Drug Recall Systems in Pharmaceutical Regulation: Regulatory Frameworks, Procedures, and Global Perspectives

Drug recall is a critical regulatory mechanism implemented to protect public health by removing defective, unsafe, or non-compliant pharmaceutical products from the market. Despite stringent regulatory approval processes, issues related to manufacturing defects, contamination, labeling errors, stability failures, and post-marketing safety concerns may lead to drug recalls. Regulatory authorities across the world, including the Central Drugs Standard Control Organization (CDSCO), the United States Food and Drug Administration (US FDA), the European Medicines Agency (EMA), and other national agencies, have developed structured recall guidelines and rapid alert systems to ensure timely withdrawal of defective products. Drug recalls are typically classified based on the level of health risk and may be executed at different levels of the distribution chain, including wholesale, retail, and consumer levels. Effective recall management involves risk assessment, recall communication, product traceability, documentation, and recall effectiveness checks. Pharmacovigilance systems also play an important role in identifying adverse drug reactions and quality defects that may lead to product recalls. This review article provides a comprehensive overview of drug recall systems, including causes of recalls, regulatory frameworks in India and other countries, recall classification, recall procedures, rapid alert systems, and global recall trends. The article also discusses challenges in recall implementation and provides recommendations to strengthen drug recall systems and regulatory coordination worldwide.