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What To Know About Drug Recalls in the United States

Medications are routinely tested in the United States to ensure they’re safe for consumer use. Even after a medication receives clearance, the U.S. Food and Drug Administration (FDA) continues to monitor them for potential recalls. This guide covers everything you need to know about drug recalls, including how they work, the different classes, and what to do if you’re in possession of medications on the recalled list.

What Is a Drug Recall?

Drug recalls occur when a pharmaceutical company voluntarily removes a drug from the market. The most common reason to recall a drug is that it’s defective. However, a drug may also be removed from the market for being harmful. Other common reasons for recalls may include mislabeled products, poorly packaged products, contaminated products, poorly manufactured, or ineffectiveness. Additionally, the FDA routinely monitors drug manufacturer warehouses for safety. If the FDA identifies any problems during these routine inspections, they may issue a drug recall.

How Drug Recalls Work

The FDA actively monitors the safety of drugs. Consumers who believe there may be a problem with a drug can report their concerns to the FDA. The FDA continually monitors complaints and issues a recall if they believe one is warranted. The FDA typically works closely with the drug manufacturer, which often leads to voluntary recalls. The public may or may not be aware of these complaints. In fact, the FDA may only notify the public when a drug is deemed dangerous.

However, while the FDA may not notify consumers of potential drug complaints, this information is still available to the public. You can always visit the FDA website to check current complaints. You can also sign up for the FDA’s regular newsletter to learn about current concerns and to learn more about medications.

Once the FDA decides to recall a drug, they’ll issue a public warning that includes information about the drug and why they’re recalling it. They’ll also publish an FDA Enforcement Report, which lists how they plan to deal with the unsafe drug.

Classes of Drug Recalls

In the United States, drug recalls are categorized into three classes:

  1. Class I: Recalled drugs that pose a serious threat to consumers.
  2. Class II: Recalled drugs that may pose a serious threat to consumers.
  3. Class III: Recalled drugs that violate FDA regulations but are not likely to cause injury or illness.

You might be surprised to learn that drug recalls are common. It’s estimated that as many as 1,200 drugs are recalled each year. It’s hard to get the actual number since not all drug recalls are published. Drug recalls are often done to protect consumers in the event of a dangerous drug. With a large percentage of drug recalls being voluntary, most of them won’t cause extensive harm to the consumer. In fact, fewer than one in ten drug recalls are Class I. The majority of drug recalls are Class II.

The FDA also regulates food, supplements, and medical devices. Certain medical products, including tongue depressors, implants, or mesh, can all endanger a person if defective. The FDA doesn’t commonly issue recalls on medical devices. Recalled products are usually due to a voluntary recall that occurs after the manufacturer identifies a design or use defect.

Consumers injured by a defective drug or medical equipment may have legal rights. Discussing your case with a product liability lawyer can help you determine your options and potentially recover related costs to the injury.

What To Do With Recalled Drugs

If you have any drugs in your home that are now on the FDA recalled list, you’ll want to determine the reason for the recall. For example, some drugs may be unsafe for pregnant women, but if you’re not currently pregnant and have no plans to, the drug may still be considered safe for you. If you’re unsure, it’s best to hold off and discuss use with a medical professional.

If you have possession of a recalled drug, you may be able to return it to the pharmacy. Most pharmacies and stores are required to issue a refund if the product has been recalled. You can also ask the pharmacist for a recommendation on what products to replace the recalled item with.

If you believe the medication has already impacted you and caused injury or illness, stop taking it but hold onto the bottle. You may need the physical evidence if you pursue legal action against the manufacturer to recover your damages. Product liability laws may provide you with legal justification to seek compensation if a drug causes you injury.