Ensuring Product Safety: A Comprehensive Retrospective Study of USFDA Drug Recalls (2019–2023)

Abstract

Purpose

Despite stringent regulations enforced by the United States Food and Drug Administration (USFDA), numerous drug products still enter the market without adequate assurance of safety and efficacy, resulting in frequent recalls. To explore the real picture of such recalls, this analysis focuses on the USFDA drug recalls with a glance at medical devices, food products, biological products, cosmetics, tobacco products, and veterinary products from 2019 to 2023. The research aims to quantify and categorize these drug recalls, examining various contributing factors to recommend strategies for minimizing future recalls. Additionally, it investigates the influence of global and national crises, such as the COVID-19 pandemic, on the USFDA’s drug recall process.

Methods

Data from USFDA Enforcement reports were collected and sorted, and descriptive statistics were used to analyse drug recalls.

Results

Between 2019 and 2023, the USFDA documented 31125 recalls, of which 6217 involved drug products from 593 different companies. These recalls are frequently initiated by the companies themselves, with primary causes including sterility assurance failures, contamination, and improper storage conditions.

Conclusions

Drug recalls are a double-edged sword: while they are essential for protecting public health, they can also disrupt supply chains and lead to drug shortages, especially when there are no alternatives available. To prevent such disruptions, strict adherence to current Good Manufacturing Practices, along with comprehensive internal audits and rigorous USFDA inspections are vital for manufacturers to maintain quality standards and minimize the risk of recalls.