Analysis of Fda Reported Drugs and Biologics Recall: A Ten-Year Review

Purpose The purpose of this study is to systematically analyze and compare drugs and biologics recalls from 2015 to 2025 to identify the key reasons, trends and regulatory implications Methods A retrospective analysis was conducted using recall data collected from FDA enforcement report from 2015 to 2025. Descriptive statistics were used to evaluate the recall trends and patterns. Results From 2015 to 2025, 12869 drugs were recalled and 5916 biologics were recalled because of cGMP deviations, sterility issues, contamination issue, labelling issue, specification issue and donor related issue. Majority of the recalls were voluntarily initiated by manufacturers because of the above-mentioned issues. Conclusion Drug recalls occurred more frequently when compared to biologics recalls from 2015–2025. To lower the frequency of recalls and guarantee patient safety, manufacturers must implement proactive risk-based controls, strong quality management systems and stricter regulatory compliance.