FDA Drug Recalls

When the FDA or a pharmaceutical company removes a drug from the market, what does it mean?

By , Attorney (Northwestern University School of Law)

In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off the market. Sometimes the U.S. Food and Drug Administration (FDA) requests the recall, while at other times the recall is initiated by the manufacturer. Either way, the FDA plays a key role in the process.

Recent examples of drug recalls include:

  • McNeil Consumer Healthcare's April 2010 recall of certain batches of over-the-counter children's drugs, including liquid Tylenol, Motrin, and Zyrtec because of possible contaminants.
  • The 2008 recall of Baxter Healthcare's anticoagulant drug, heparin, because the FDA found contaminants in the drug that caused severe injury and death in some people. (For more on the heparin recall, see Nolo's article Heparin Recall and Litigation.)
  • Crestor and other cholesterol drugs

Read on to learn how the FDA approves and monitors drugs, when and how recalls occur, and how to notify the FDA if you suspect a serious problem with a drug.

What Is 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.

The FDA's Center for Drug Evaluation and Research evaluates new drugs to ensure they work correctly and that their health benefits outweigh known risks. The Center for Drug Evaluation and Research does not test the drugs itself. Instead, a new drug's manufacturer tests the product on both animals and humans, and then sends the results to the center. Experts at the Center for Drug Evaluation and Research review the studies and determine whether the drug is safe, effective, and of good quality.

Once a drug is approved by the FDA and on the market, the manufacturer must review and report any problems linked to the drug. Consumers can report problems directly to the FDA through the MedWatch program. (To learn more about how to report a drug problem, see the "Reporting Defective Drugs: MedWatch" section below.) Sometimes, the FDA requires the manufacturer to conduct additional clinical trials involving the drug.

When Are Drugs Recalled?

A recall occurs when a drug 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. This could be because of any of the following:

  • The drug causes dangerous side effects.
  • The FDA has discovered a safer alternative to the drug.
  • Consumers use the drug improperly and that unauthorized use causes serious injury or death.

Other times, the drug is considered safe if manufactured correctly, but a manufacturing error or contamination incident makes a particular batch of the drug unsafe.

Types of Recalls

Recalls are grouped by the severity of the danger posed by the recalled drug. Here are the different types of recalls.

  • Class I recall. There is a reasonable probability that a consumer's use of or exposure to a drug will cause serious health problems or death.
  • Class II recall. Use of or exposure to a drug may cause temporary or medically reversible health problems, or there is a remote risk that the drug will cause serious health problems.
  • Class III recall. Use of or exposure to a drug is not likely to cause adverse health consequences.
  • Market withdrawal. The drug has a minor problem that the FDA would not normally monitor. For example, the manufacturer removes a drug from the market because of after-manufacturing tampering and not because of a problem with the drug itself.
  • Medical device safety alert. A medical device has an unreasonable risk of causing substantial harm. In some case, these situations also are considered recalls.

How Does a Recall Happen?

Recalls come about in one of three ways.

  • The manufacturer initiates the recall. This is the most common method of recall.
  • The FDA requests that the manufacturer voluntarily recall the drug. In this scenario, the FDA informs the manufacturer that its product is defective and suggests or requests that the manufacturer recall the drug.
  • The FDA orders the manufacturer to recall the drug. If the manufacturer refuses to recall the drug, the FDA can go to court to force the manufacturer to recall the drug or to get legal authority to seize the drug.

When a manufacturer initiates a drug recall, it must notify the FDA, submit progress reports on the recall, and follow up to make sure the recall was successful. If the FDA requests a recall, the manufacturer is expected to comply. Rarely does the FDA need to seize the drug itself. The FDA publishes guidelines for manufacturers to follow when recalling drugs. These are found in Title 21 of the Code of Federal Regulations, Part 7. (To view the Code of Federal Regulations, visit Nolo's Legal Research Center.)

Notice of Recalls

There are several ways that the manufacturer and the FDA notify consumers about a recall.

Direct notification. The drug manufacturer must notify its direct accounts (such as wholesalers or chain drug stores) about the recall. The notification must do all of the following:

  • Inform the reseller that the drug has been recalled.
  • Request that the reseller stop distributing the drug.
  • If appropriate, request that the reseller notify its customers about the recall.
  • Instruct the reseller on what to do with the drug.

Public notification. The FDA maintains a list of drug and medical device recalls on its website (www.fda.gov) called Recalls, Market Withdrawals, & Safety Alerts. For the most part, this list includes Class I safety recalls. To find out about Class II and Class III recalls, you can check the FDA's weekly Enforcement Reports, also found on the FDA website.

Media coverage. Often, if a drug recall affects many people, or the recalled drug causes severe injury or death, the media will report on the recall.

Reporting Defective Drugs: MedWatch

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

  • serious adverse events (death, risk of dying, admission to the hospital, prolonged hospital stay, disability, or other serious health consequences)
  • drug quality problems, and
  • potential or actual errors in administering the drug.

Consumers can report problems with drugs or medical devices by filling out the MedWatch Online Voluntary Reporting Form (available on the FDA's website at www.fda.gov). Consumers can report problems with vaccines to the Vaccine Adverse Event Reporting System (on the U.S. Department of Health and Human Services' website at www.hhs.gov).

What to Do If You Are Injured by a Drug

If you have been harmed by use of a pharmaceutical or over-the-counter drug, you may be able to bring a product liability claim against the drug manufacturer. To learn more about product liability law, see Nolo's article Product Liability Claims Involving Pharmaceutical Drugs.

This article contains information from the FDA website.

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