Drug Withdrawals and Recalls: Why Medications Get Removed from the Market

Every year, dozens of medications disappear from pharmacy shelves-not because they’re outdated, but because they’re dangerous or don’t work. The FDA doesn’t remove drugs lightly, but when the evidence piles up, it has to act. And yet, the system has taken far too long to catch up with the science. Patients have been stuck on drugs that later proved ineffective, sometimes for years, while regulators scrambled to respond. The process of pulling a drug off the market is complex, slow, and often painfully delayed-but recent changes are finally starting to fix it.

How a Drug Gets Removed from the Market

Not all drug removals are the same. Some are voluntary, others are forced. When a company decides to stop selling a drug because of low sales or manufacturing issues, that’s a voluntary withdrawal. But if the FDA steps in because the drug is unsafe or doesn’t deliver on its promised benefits, that’s a mandatory withdrawal-and it’s where the real problems have historically occurred.

The FDA defines a drug as "withdrawn from sale" only when the manufacturer stops distributing it due to safety or effectiveness concerns. A temporary stockout? That doesn’t count. A supply chain hiccup? Not a withdrawal. Only when the reason is tied to patient risk does the FDA treat it as a formal removal.

There are two main approval paths that determine how a drug can be pulled: traditional approval and accelerated approval. Traditional approval requires solid proof of benefit before the drug hits the market. Accelerated approval, on the other hand, lets drugs reach patients faster based on early signs-like tumor shrinkage in cancer trials-that are believed to predict real clinical benefit. But that benefit must be confirmed later. If it isn’t? That’s when the withdrawal process kicks in.

The Long Wait: How Long It Used to Take

Before 2023, the FDA’s withdrawal process was broken. Take Makena, a drug approved in 2011 to prevent preterm birth. By 2020, a large confirmatory trial showed it didn’t work. But the FDA didn’t pull it until 2022-over two years after the evidence was clear. That’s 1,500 days of patients still being prescribed a drug with no proven benefit.

Research from Penn LDI found that, on average, it took the FDA 46 months (almost four years) to withdraw a drug that had been approved under the accelerated pathway. For some cancers, like small cell lung cancer, over 40% of eligible patients received drugs that were later pulled. That’s not just a delay-it’s a public health failure.

Why so slow? The old system had no deadlines. The FDA would notify the manufacturer, wait for feedback, hold meetings, open public comment periods, and then decide. All of this could stretch out for years. Meanwhile, doctors kept prescribing. Patients kept taking the drugs. And the FDA had no real power to speed things up.

The 2023 Reform: What Changed

In December 2023, Congress passed the Consolidated Appropriations Act, and with it, the FDA finally got real authority to act faster. The new law created a streamlined withdrawal process specifically for drugs approved under accelerated approval. Now, the FDA can move quickly if:

• The drug sponsor fails to conduct required post-approval studies on time
• The confirmatory study doesn’t prove the drug works
• Real-world data or independent research shows the drug is unsafe or ineffective
• The company promotes the drug with false or misleading claims

This isn’t just about speed-it’s about structure. Under the new rules, the FDA must give the manufacturer notice within 30 days, offer a meeting within 60 days, and issue a final decision within 180 days. That’s a huge shift from the old, open-ended process.

The first drug pulled under this new system was an ALS treatment in August 2023. It wasn’t the first drug to be withdrawn, but it was the first to be removed under a clear, timed process. The FDA also created a dedicated team of 12 scientists and doctors to handle these cases, with a goal of cutting withdrawal time from 46 months to under 12.

Who Gets Affected-and How

When a drug is pulled, it doesn’t just vanish from shelves. It ripples through the healthcare system.

Doctors have to switch patients to alternatives. Oncology practices report it takes an average of 72 hours to develop new treatment plans once a drug is withdrawn. Pharmacists struggle to keep up: a 2022 survey found 63% still couldn’t reliably interpret the FDA’s Orange Book listings, which track which drugs are approved and which have been withdrawn.

Patients are the ones who pay the biggest price. Many don’t know their drug is under review. One metastatic breast cancer patient shared online: "I was on [withdrawn drug] for 18 months before the confirmatory trial failed. My oncologist said it was standard of care at the time-but now we know it didn’t actually help."

Reddit threads like "How many of you have been on drugs later withdrawn?" have hundreds of responses. Over 85% of commenters said they were worried their current prescriptions could vanish without warning. Patient advocacy groups are pushing for better communication-like mandatory letters to patients or alerts in electronic health records.

Why Oncology Is Ground Zero

More than 40% of all accelerated approvals are for cancer drugs. That’s why the oncology sector has seen the highest number of withdrawals. Between 2010 and 2020, about 12.7% of accelerated approvals were eventually pulled. That’s one in eight drugs.

Why? Because cancer is complex. Drugs that shrink tumors don’t always extend life. The FDA used to approve based on tumor response rates-quick, measurable outcomes. But survival, quality of life, and side effects matter more. When follow-up trials showed no survival benefit, the drugs had to go. And patients had already been exposed for years.

One drug, approved for small cell lung cancer, was given to 41% of eligible patients before being withdrawn. That’s thousands of people who endured toxic side effects for no benefit. The new 2023 rules are designed to stop this from happening again.

Global Differences: How Other Countries Handle It

The U.S. wasn’t alone in struggling with this problem-but it was one of the slowest. The European Medicines Agency (EMA) and Health Canada have long used "conditional approval," where drugs are approved with strict requirements to prove benefit within a set time. If the sponsor doesn’t deliver, the drug is pulled automatically.

The FDA didn’t have that power until 2023. Its main tool was Postmarketing Required studies (PMRs), which could only be forced in limited cases. The new law borrows from this international model, giving the FDA clearer authority to tie approval to performance.

That’s not just a legal change-it’s a cultural one. The U.S. is moving from a "approve first, ask questions later" mindset to one that demands accountability. It’s not perfect, but it’s progress.

What’s Next: Real-World Evidence and the Future

The FDA is now testing a pilot program using real-world data from Flatiron Health, a company that collects treatment outcomes from thousands of cancer clinics. Instead of waiting for slow, expensive clinical trials, regulators may soon use actual patient data to spot drugs that aren’t working.

By 2027, Evaluate Pharma predicts a 25% increase in drug withdrawals as the new system kicks in. That could mean $8.2 billion in lost annual sales-but also fewer patients harmed.

Pharmaceutical companies are adapting too. Nearly 80% of major oncology drugmakers now include withdrawal scenarios in their risk management plans. They’re building contingency strategies, not just hoping they won’t get caught.

Still, concerns remain. Industry groups warn that too-fast withdrawals could scare off innovation in high-risk areas like rare diseases. But patient advocates say the bigger risk is doing nothing. "The true test," says the National Organization for Rare Disorders, "is how quickly the FDA acts when the evidence is clear."

The Makena case exposed a system that valued speed over safety. The 2023 reforms are the first real step toward fixing that. It’s not about taking drugs away-it’s about making sure patients only get medicines that actually help.

What You Should Do Now

If you’re taking a drug that was approved under accelerated approval-especially for cancer, rare diseases, or chronic conditions-ask your doctor if it’s been reviewed for withdrawal. Don’t assume it’s safe just because you’ve been on it for years. Ask if there’s a confirmatory study underway, and whether results are available.

Pharmacists can help you check the FDA’s Orange Book for updates. If your drug is pulled, don’t stop taking it suddenly-work with your provider to switch safely. And if you’ve been on a drug later withdrawn, your experience matters. Share it with patient advocacy groups. Your voice helps push for faster change.

The system isn’t perfect yet. But it’s moving. And for patients who’ve waited too long for answers, that’s the first real sign of progress.