A Multi-Perspective Narrative Review of the Impact of Drug Recalls on Pharmaceutical Companies & Mitigation Strategies

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Date

2025

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Saudi Digital Library

Abstract

Introduction: Drug recalls, though essential for public health protection, they trigger financial and reputational impacts on pharmaceutical companies. Aims: This narrative review study aim is to identify the financial and reputational impacts of drug recalls on major pharmaceutical companies, effective post-recall response strategies, and best practices for recall prevention. Methodology: A search was conducted using various electronic databases, including PubMed, Web of Science, Google Scholar, websites related to pharmaceutical companies, and news articles. Keywords related to recalls in pharmaceutical industry were used. This search was limited to literature published between 2014 and 2025. This review included original research articles, review articles, and case studies. Results: The review identified significant financial and reputational impacts resulting from drug recalls, including litigation costs, operational losses, and diminished brand trust. Identified effective recall strategies included regulatory compliance, transparent communication, contingency planning, delegated authority, recall simulations, insurance coverage (including Directors and Officers D&O), strong documentation, closed-loop recall systems, and diverse board leadership. Moreover, compliance with manufacturing standards, ongoing quality control, Quality by Design (QbD) adoption, system integration, and global recall databases, may prevent recalls. Conclusion: This review underscores the importance of strategic recall management, legal preparedness, and preventive quality measures. The ranitidine example illustrates how outcomes can vary based on company response, emphasising the need for proactive planning, effective management, and integrated systems to minimise harm and preserve corporate reputation.

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Pharmaceutical companies, Drug recall, US Food and Drug Administration, Financial, Reputational, Impact, Ranitidine, Zantac

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