What is the Process for Recalling a Drug?

Medications go through extensive testing and regulatory review before reaching consumers, but no system is perfect. Occasionally, after a drug has entered the market, unforeseen problems arise. These issues can range from contamination in manufacturing to newly discovered side effects. When issues with a drug are detected, the process of recalling it is initiated. During recall, the manufacturer must act swiftly to reduce further harm to public health ¹.

A drug recall is the process of removing, or recalling, a pharmaceutical product from the market because it is defective or potentially harmful. This can occur for various reasons, including contamination, mislabeling, incorrect dosage, adverse side effects, or failure to meet quality standards. While recalls are sometimes initiated voluntarily by the manufacturer, they can also be requested or mandated by regulatory bodies such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) ^2,3.

The process usually begins when a problem is detected. This could be reported by healthcare providers, patients, pharmacists, or the manufacturer’s own quality control system; in some cases, post-market surveillance or adverse event monitoring reveals patterns that indicate a drug may pose a safety risk. Once a concern is raised, the manufacturer typically investigates the issue to determine the severity and scope of the problem ⁴.

If the issue is serious, the manufacturer may notify the appropriate regulatory authority. In the United States, the FDA evaluates the evidence and classifies the recall based on the level of risk. A Class I recall is the most urgent, involving products that could cause serious health problems or death. Class II recalls involve drugs that might cause temporary or medically reversible harm, while Class III recalls are for products that are unlikely to cause harm but violate labeling or manufacturing regulations ⁵.

Following classification, a recall strategy is developed. This includes deciding how the public and affected parties will be informed, how the product will be removed from circulation, and how effectiveness will be monitored. Notification often involves press releases, direct contact with pharmacies, hospitals, or physicians, and updates to official drug safety websites. Patients who are using the affected drug may be advised to stop taking it and return the product, or they may be prescribed an alternative ^6,7.

In parallel, regulatory agencies often inspect the manufacturing facilities involved to determine whether the problem was an isolated event or indicative of broader compliance issues. These investigations can lead to penalties, corrective action requirements, or even facility shutdowns in extreme cases ^8,9.

Drug recalls, while concerning, are a sign that post-market safety systems are working. The goal is always to act quickly, reduce harm, and restore trust in the healthcare system. When carried out responsibly and transparently, the process of recalling a drug can ultimately reinforce public safety and improve industry standards.

References

1. Natof, T. & Pellegrini, M. V. Food and Drug Administration Recalls. in StatPearls (StatPearls Publishing, Treasure Island (FL), 2025).
2. Quality defects and recalls | European Medicines Agency (EMA). https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/quality-defects-recalls (2018).
3. Virginia, Y. C. T., BS Pharm, RPh Clinical Pharmacist/Freelance Medical Writer Haymarket. Overview of the FDA’s Drug-Recall Process. https://www.uspharmacist.com/article/overview-of-the-fdas-drugrecall-process.
4. Marks, H. Drug Recalls: Why They Happen and What You Should Do. WebMD https://www.webmd.com/a-to-z-guides/what-is-a-drug-recall.
5. Office of Regulatory Affairs. Recalls Background and Definitions. FDA (2019).
6. FDA strengthens Public Warning and Notification of Recalls – ECA Academy. https://www.gmp-compliance.org/gmp-news/fda-strengthens-public-warning-and-notification-of-recalls.
7. Center for Drug Evaluation and Research. FDA’s Role in Drug Recalls. FDA (2024).
8. F.D.A. Considers Further Penalties in Drug Recall – The New York Times. https://www.nytimes.com/2010/05/28/business/28drug.html.
9. Nagaich, U. & Sadhna, D. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history. Int J Pharm Investig 5, 13–19 (2015). DOI: 10.4103/2230-973X.147222