Guide to FDA Drug Recalls

In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off the market. The Food and Drug Administration (FDA) plays a key role in this process. It not only oversees drug safety in general, but also sets the rules for when and how companies should issue recalls. In rare cases, the FDA will even go to court to force a company to take a drug off the market. A recall is an important public health measure, and can also have a significant impact on product liability lawsuits against the drug manufacturer.

The FDA's Role in Monitoring Drugs

The FDA is responsible for making sure that products like drugs, vaccines, and medical devices are safe and effective.

Approval of new drugs. The FDA's Center for Drug Evaluation and Research (CDER) evaluates new drugs to ensure they work correctly and that their health benefits outweigh known risks. CDER does not test the drugs itself. Instead, manufacturers conduct FDA-mandated research, including clinical trials, and send the results to CDER. Experts at CDER then evaluate this research to determine whether each drug is safe, effective, and of good quality.

Addressing problems with a drug. The FDA continues its oversight role after it approves a drug and the manufacturer puts it on the market. The agency inspects manufacturing facilities, and also collects information from drug manufacturers, healthcare providers, and people using the medication.

If there are problems with a drug, the FDA could recommend that the manufacturer add additional information or warnings to ensure that the medication is prescribed and used safely. In rare and serious cases, the FDA can also request a recall.

How the FDA and Drug Companies Recall Unsafe Drugs

A recall occurs when a manufacturer or the FDA decides that a pharmaceutical drug is not safe and should be removed from the market. Sometimes a recall is necessary because new research shows that the drug is too dangerous for use by consumers. A drug can also be recalled if a manufacturing error or contamination incident makes a particular batch of a drug unsafe.

The FDA Classifies Recalls Based on Dangerousness

The greater the danger a product poses to the public, the more involved the FDA will be in overseeing its removal from the market. The agency has three classifications for recalls.

A Class I recall means the FDA thinks there's a "reasonable probability" that a drug will cause serious health problems or death.

A Class II recall means that there is either a "remote" risk a drug will cause serious health problems, or a more significant risk that the drug will cause temporary or treatable health problems.

A Class III recall means that use of or exposure to a drug is not likely to harm patients, but there is still a problem a manufacturer needs to fix. For example, a drug that has been mislabeled could be subject to a Class III recall.

In addition, the FDA issues medical device safety alerts when medical devices pose an unreasonable risk to their users. It can also be involved in so-called "market withdrawals," which is when a drug is pulled from the market for a reason that isn't the legal responsibility of the manufacturer or distributor. For example, if a drug has been tampered with it could be subject to a market withdrawal.

Initiating a Drug Recall

When the FDA or a manufacturer thinks a drug is unsafe, a recall can begin in one of three ways.

First, drug manufacturers can initiate recalls themselves. This is the most common type of recall.

Second, the FDA can request that the manufacturer initiate a voluntary recall. The agency will inform the manufacturer that it believes a drug is dangerous, provide its evidence for this view, and request that the company initiate a recall.

Third, in rare cases the FDA will force a manufacturer to recall a drug. This only happens if the agency has failed to convince a company to voluntarily take a drug off the market. If this happens, the FDA can seek a court order forcing the company to initiate a recall.

A manufacturer must notify the FDA if it initiate a drug recall, keep the agency informed of its progress, and follow procedures mandated by federal regulations.

Notifying the Public of a Drug Recall

Both a drug manufacturer and the FDA will spread the word about a recall.

Direct notification. A drug manufacturer must provide notice of the recall to drug stores, wholesalers, and anyone else who provides the drug directly to the public. This notice must include a request to stop distributing the drug, and can include a request that the reseller notify its customers about the recall.

Public notification. The FDA's website includes a page that tracks recalls, market withdrawals, and safety alerts. For the most part, this list is focused on Class I safety recalls. But the agency also issues weekly enforcement reports that provide information about Class II and III recalls.

In addition, if a drug has caused very serious or widespread health problems, news of a recall can be spread online by the media.

Consumers Can Report Dangerous Drugs to the Government

The FDA encourages consumers and healthcare workers to report problems they suspect are caused by drugs, vaccines, or medical devices, including:

• serious health consequences including death, disability, and hospitalization
• problems with drug quality, and
• errors in administering a drug.

Consumers can report problems with drugs or medical devices through the FDA's MedWatch program, which includes an online form. Consumers can also report problems with vaccines to the Department of Health and Human Services through its Vaccine Adverse Event Reporting System.

How a Drug Recall Could Affect a Product Liability Claim

The purpose of a recall is to protect the public from a dangerous drug or other product, not to compensate consumers for harms they've already suffered. Civil lawsuits filed by people who've been hurt by a drug use a different set of rules. The fact that there's been a recall can be important in these lawsuits, but isn't the deciding factor for whether a plaintiff receives compensation.

Recalls Don't Automatically Make Manufacturers Liable

Most lawsuits over harms caused by a drug use a so-called "strict liability" theory. Strict liability means the plaintiff has to show that:

• the drug was dangerous because of a problem with its design, errors in the manufacturing process, or the absence of necessary warnings
• the manufacturer intended the drug to reach consumers without any changes, and
• the plaintiff was harmed as a result of taking the drug.

So a plaintiff can't just point out that a drug has been recalled, or show that other people were hurt by it. In their own lawsuit they have to prove that they took the drug as directed, and that their health suffered as a result.

Recalls Don't Usually Help Manufacturers Avoid Liability

A recall doesn't replace someone's right to file a lawsuit if they believe they've been hurt by a manufacturer's drug. Just because a company has taken steps to protect other consumers doesn't mean they aren't legally responsible for the harm they've already caused.

But consumers are responsible for heeding warnings about the dangers of using a drug. So, if someone takes a drug after the manufacturer has recalled it and explained the potential danger, they may find it difficult or impossible to show that the manufacturer is liable.

Using a Recall as Evidence Against the Drug Manufacturer

If a drug has been recalled, the reasons for the recall could be important to a product liability lawsuit. For example, scientific studies showing a drug's specific health consequences could help a plaintiff prove that their own health issues were caused by the drug, and not some other factor.

But it's much less likely that a plaintiff will be able to use evidence of the recall itself against the manufacturer. In many jurisdictions, including federal court, plaintiffs generally can't use a recall (including the company's statements about why the recall is necessary) to help establish a manufacturer's liability. The theory is that this legal protection makes companies more likely to act quickly to address potential dangers with their products. (Fed. R. Evid. 407 (2024).)

In many states, though, plaintiffs have more leeway to use a recall against a drug manufacturer. In Connecticut, for example, plaintiffs in strict liability cases can use so-called "subsequent remedial measures," including recalls, to help prove a company's liability. (Conn. Code. Evid. 4-7 (2023).)

These rules can be complicated, and even a court that usually excludes this kind of evidence might allow it in certain situations. And keep in mind that, if a company has been forced to issue a recall by the government, it won't be able to argue that it should get credit for voluntarily trying to address the danger.

What to Do If You Are Injured by a Drug

If you've been harmed by a medication, you can learn more about product liability claims over prescription drugs. If you're wondering how a recall might affect your case, or have other questions about your own situation, you may find it helpful to speak with an attorney.

This article contains information from the FDA website.