How Many Drugs Does the FDA Recall Every Year? A Look at the Data

October 8, 2025 •

3 min read

In 2023, the U.S. Food and Drug Administration (FDA) saw 1,296 pharmaceutical recalls, a number that highlights the ongoing challenges in drug quality and safety. Understanding the answer to 'How many drugs does the FDA recall every year?' reveals a complex system designed to protect public health.

Quick Summary

The FDA oversees hundreds to thousands of drug recalls annually due to safety, quality, and labeling issues. This overview details the recall process, the official classification system, and the most common reasons a drug is pulled from the market.

Key Points

Annual Numbers Vary: The number of FDA drug recalls fluctuates yearly, with recent years seeing over a thousand recalls, such as the 1,296 in 2023.
Recall Classifications: Recalls are rated by risk: Class I (serious harm/death), Class II (temporary harm), and Class III (unlikely to cause harm).
Primary Causes: Most recalls stem from manufacturing defects, contamination, sterility issues, and incorrect labeling or potency.
Voluntary Action is Key: The vast majority of recalls are initiated voluntarily by pharmaceutical companies, often at the FDA's request.
Stay Informed: Patients can find up-to-date recall information on the FDA's website, recalls.gov, or by speaking with their pharmacist.
Consult a Professional: If a medication is recalled, always consult a doctor or pharmacist before stopping treatment.
A Functioning System: Drug recalls are not necessarily a sign of declining drug quality, but rather an indication of a vigilant regulatory system protecting public health.

The Scale of FDA Drug Recalls: A Look at the Numbers

The number of drug recalls in the United States varies annually. While over 14,000 drug recalls occurred in the last decade, specific annual figures highlight this fluctuation. For instance, 2019 saw 2,163 recalls, while 2012 had 459. In 2023, there were 1,296 recalls, indicating that such activity remains a consistent aspect of the pharmaceutical industry. These numbers represent an active system working to remove potentially harmful products from the market. Most recalls are voluntarily initiated by manufacturers, often at the FDA's request.

Common Reasons for Medication Recalls

Drugs are recalled due to various issues, primarily deviations from Current Good Manufacturing Practice (CGMP). These issues can impact a medication's safety, identity, strength, quality, or purity.

Key Triggers for Recalls:

Contamination: This frequently includes harmful microorganisms, chemical impurities like nitrosamines, or foreign particles.
Manufacturing and Sterility Issues: Problems during production, such as inadequate equipment cleaning or failure to ensure sterility for injectable products, are major causes. Incorrect storage temperatures can also lead to recalls.
Mislabeling: Errors on packaging, like wrong drug names, incorrect dosages, or missing warnings, can result in patients taking the wrong medication or dose.
Incorrect Potency or Purity: Recalls can occur if a drug has too much or too little active ingredient or contains impurities from degradation.
Adverse Reactions: Sometimes, unexpected side effects emerge after a drug is widely used, leading to a recall.

Understanding the FDA's Recall Classification System

The FDA classifies recalls into three categories based on the potential health hazard. This system helps healthcare providers and patients understand the urgency and danger of a recalled product.


Classification	Severity of Hazard	Example
Class I	Using the product has a reasonable probability of causing serious adverse health consequences or death.	A contaminated injectable drug or a label mix-up on a critical medication.
Class II	Using the product may cause temporary or medically reversible adverse health consequences, or serious harm is unlikely.	An under-strength drug not for a life-threatening condition or a medication with minor contamination.
Class III	Using the product is not likely to cause adverse health consequences.	A container with a minor packaging defect or a non-critical typo on the label.

How Patients Can Stay Informed

Staying informed about drug recalls is important. If you learn your medication is recalled, do not stop taking it without consulting your doctor or pharmacist first. They can advise on the risk and provide an alternative.

Resources for Recall Information:

Check the FDA Website: The FDA's database lists recalls, market withdrawals, and safety alerts. You can search and sign up for email notifications.
Consult Your Pharmacist: Pharmacists receive recall notifications and can check if your specific prescription, by lot number, is affected.
Use Government Resources: Recalls.gov centralizes recall information from multiple federal agencies, including the FDA.

Conclusion: A Sign of a System at Work

While the annual number of drug recalls may seem concerning, it demonstrates that the regulatory system is functioning. Post-market surveillance programs like the FDA's MedWatch, which collects adverse event reports, are crucial for identifying issues not found in clinical trials. Each recall represents a successful intervention to protect public health. Continuous monitoring and reporting by manufacturers, the FDA, and consumers are vital for ensuring medication safety and effectiveness. For more information on product safety, visit the FDA's Recalls, Market Withdrawals, & Safety Alerts page.

Frequently Asked Questions

A Class I recall is the most serious. It is issued when there is a reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.

The majority of drug recalls are conducted voluntarily by the manufacturing company. This can be on the firm's own initiative or at the request of the FDA.

You can check the FDA's official drug recall database online, visit the government's central recall website at recalls.gov, or speak directly with your pharmacist, who can check the specific lot number of your prescription.

Do not stop taking a prescribed medication without first consulting your doctor or pharmacist. They will provide guidance on the specific health risk and can arrange for a safe alternative if necessary.

A recall is for products that violate FDA regulations and pose a potential health risk. A market withdrawal occurs for a minor violation that doesn't warrant legal action or for commercial reasons, and the firm removes the product on its own initiative.

Recalls happen for many reasons, including contamination, manufacturing defects, incorrect labeling or potency, and the discovery of new adverse reactions after the drug is on the market.

The FDA reviews clinical trial data and inspects manufacturing facilities, but it does not test every batch of a drug. It relies on manufacturer quality control and post-market surveillance, like reports from patients and doctors, to identify problems.