The Nuanced Answer to: What percent of FDA approved drugs are pulled?

October 10, 2025 •

4 min read

While the vast majority of drugs remain on the market, one study of drugs approved between 1990 and 2009 found that 4.2% were eventually withdrawn for safety reasons. However, answering the question of what percent of FDA approved drugs are pulled requires understanding the complex landscape of post-market drug safety actions, which includes not just full withdrawals but also recalls and black box warnings.

Quick Summary

The percentage of FDA-approved drugs completely withdrawn from the market is small, but a significantly higher portion experiences post-market safety issues leading to warnings or recalls. The distinction between withdrawals, recalls, and label changes is critical to understanding drug safety actions. Reasons for removal range from previously undetected serious side effects to manufacturing and labeling issues discovered through post-market surveillance.

Key Points

Low Withdrawal Rate: Only a small percentage of FDA-approved drugs are entirely pulled from the market, with one study finding a 4.2% rate for drugs approved between 1990 and 2009.
Higher Safety Event Rate: A much larger percentage of drugs, potentially one-third or more, receive new safety warnings, such as black box warnings, after being on the market.
Withdrawals vs. Recalls: A withdrawal typically involves fundamental safety or effectiveness issues, leading to permanent market removal, while a recall addresses manufacturing, contamination, or labeling problems, potentially affecting only specific batches.
Post-Market Surveillance is Key: Issues leading to withdrawals often emerge only after a drug is used by a much larger, more diverse population than in clinical trials, highlighting the critical role of post-market surveillance.
Common Reasons for Removal: Primary reasons for withdrawals include severe adverse effects like hepatotoxicity and cardiotoxicity, as well as failure to confirm clinical benefit for accelerated approvals.
FDA's Role: The FDA oversees recalls and withdrawals, which are most often voluntarily initiated by the manufacturer, though the FDA can mandate them in extreme cases.

Unpacking the Statistics: Withdrawals vs. Other Safety Actions

When considering the question, "What percent of FDA approved drugs are pulled?" it's crucial to look beyond a single number. While a relatively small percentage of drugs are entirely withdrawn, a larger portion faces other significant safety actions post-approval.

Total Drug Withdrawals: A study of drugs approved between 1990 and 2009 found that 22 of 528 new active substances (4.2%) were eventually withdrawn from the market. The median time between approval and withdrawal was 1,271 days, or about 3.5 years. Another analysis covering the 1997-2001 period found 10 drugs withdrawn. These numbers indicate that outright withdrawal is a relatively rare event, but it does happen. Estimates vary depending on the timeframe and specific criteria used, with some sources suggesting a post-marketing failure rate of 4-6%.
Other Post-Market Safety Issues: The percentage of drugs with post-market issues requiring FDA action is much higher. A 2017 Yale-led study published in the Journal of the American Medical Association found that nearly one-third (32%) of new drugs approved between 2001 and 2010 had new safety issues identified after approval. This often results in a black box warning—the FDA's most severe warning—or other safety communications, not a complete market withdrawal.

Why are Drugs Pulled? Key Reasons for Removal

Drug withdrawals and recalls occur for various reasons, highlighting the importance of ongoing post-market surveillance. While pre-market clinical trials are extensive, they cannot always capture rare side effects or those that only appear with long-term use across a broad, diverse population.

Safety Concerns Uncovered Post-Approval

Hepatotoxicity and Cardiotoxicity: These are two of the most common reasons for drug withdrawals. Severe and previously undetected liver or heart damage have led to the removal of several high-profile drugs from the market over the years.
Drug Interactions: Some drug interactions only become apparent when the medication is used widely in combination with other drugs that patients commonly take. An interaction that increases the risk of a serious side effect could prompt a withdrawal.
Serious Adverse Events: New findings of serious health consequences, such as increased risk of heart attacks, strokes, or even cancer, can trigger a withdrawal. Examples include Vioxx (rofecoxib) and Zantac (ranitidine).

Ineffectiveness or Inadequate Benefit

Accelerated Approval Failures: For drugs granted accelerated approval based on surrogate endpoints, failure to confirm clinical benefit in required post-marketing trials can lead to a withdrawal. One study found that 20-25% of accelerated approval drugs are later withdrawn.

Manufacturing and Quality Issues

Contamination: Contamination with unwanted substances, such as probable human carcinogens (e.g., ranitidine withdrawal), or other impurities is a common reason for recalls.
Incorrect Potency: Issues with a drug's strength or concentration, whether too high or too low, can lead to a recall.
Mislabeling: Errors in labeling or packaging can pose serious risks, especially if incorrect dosing information is provided.

The FDA's Role and Recall Classifications

For the vast majority of cases, recalls and withdrawals are voluntarily initiated by the manufacturer after dialogue with the FDA. However, the FDA has the authority to request a recall or even legally seize a product in extreme cases. The FDA classifies recalls based on the level of risk to the public:

Class I: Dangerous or defective products that could cause serious health consequences or death.
Class II: Products that may cause temporary or medically reversible adverse health consequences.
Class III: Products unlikely to cause adverse health consequences but that violate FDA laws.

Drug Withdrawal vs. Drug Recall: A Comparison

To fully understand why drugs leave the market, distinguishing between a withdrawal and a recall is essential.


Feature	Drug Withdrawal	Drug Recall
Primary Reason	Fundamental safety or effectiveness issues uncovered post-approval, or lack of confirmed benefit for accelerated approval drugs.	Manufacturing defects, contamination, mislabeling, or other minor violations.
Trigger	Unexpected and serious adverse effects, non-confirmation of clinical benefit, or negative benefit-to-harm ratio.	Quality control problems, discovery of impurities, or packaging errors.
Frequency	Relatively rare, typically affecting a small single-digit percentage of new approvals.	More frequent, with thousands of products recalled annually across all FDA-regulated items (including food and devices).
Risk Level	Often involves serious health consequences, potentially severe injury or death.	Can range from serious (Class I) to unlikely (Class III), depending on the specific issue.
Outcome	Product is permanently removed from the market.	Removal of the specific defective batch or product, with the overall drug potentially remaining available.

How Post-Market Surveillance Protects Public Health

Post-market surveillance is the ongoing process of monitoring the safety of drugs after they have been approved by the FDA and made available to the public. This process includes:

Adverse Event Reporting: Healthcare professionals and consumers can report adverse events to the FDA's MedWatch program.
Analysis of Real-World Data: The FDA analyzes data from large populations, which can reveal rare side effects that were not evident during pre-market clinical trials.
Confirmatory Trials: Manufacturers of drugs approved through accelerated pathways are required to conduct follow-up trials to verify the drug's clinical benefit.
Labeling Changes: As new safety information emerges, the FDA can require manufacturers to update a drug's label with new warnings or precautions.

The Takeaway

Ultimately, while the percentage of FDA-approved drugs that are completely pulled from the market is low, this metric alone does not represent the full picture of post-market safety. The FDA's multi-layered approach, which includes voluntary recalls, warnings, and continuous surveillance, is a crucial part of protecting public health. Patients should understand that the journey of a drug doesn't end with its approval but continues with a cycle of monitoring and, when necessary, corrective action. The system, while not flawless, is designed to identify and address safety issues as they emerge, ensuring that the risk-benefit profile of a medication remains favorable. Visit the official FDA website for the latest recall information.

Frequently Asked Questions

A drug recall is typically initiated to address specific manufacturing or labeling issues, like contamination or mislabeling, and may only affect certain product batches. A drug withdrawal occurs when a drug is removed from the market for fundamental safety or effectiveness reasons, often due to serious, previously unknown adverse effects.

No, FDA approval is a conclusion that a drug's benefits outweigh its known risks for its intended use, based on the data available at the time of approval. The FDA requires continuous monitoring, and new safety issues can emerge after widespread use.

Studies show that while total withdrawals are rare, a significant portion of FDA-approved drugs—one study suggested nearly one-third—may require new safety warnings or labeling changes in the years following approval.

Common reasons include the discovery of serious adverse effects not seen in clinical trials, such as hepatotoxicity (liver damage) and cardiotoxicity (heart damage), or the failure to confirm clinical benefits for drugs approved via the accelerated pathway.

The time varies. One study found the median time between FDA approval and withdrawal for safety reasons was about 3.5 years. The FDA acts as quickly as possible once a serious safety signal is identified and confirmed.

Yes, you can check the FDA's website, which publishes weekly enforcement reports detailing recalls, market withdrawals, and safety alerts. You can also consult your pharmacist or physician.

A black box warning is the FDA's most stringent warning, designed to call attention to a drug's serious or life-threatening side effects. It is a step taken when new risks are identified, but the drug is not yet pulled from the market.