What Is the FDA’s Process for Recalling Dangerous Drugs?

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It seems as though a new medication comes onto the market every week. Many of these drugs literally save people’s lives. However, in the rush to be the first company to put a medication for a particular condition on the market, a pharmaceutical manufacturer could make a mistake that threatens the lives of those who take it.

There are often more than enough potential side effects that do the same thing. The last thing you and others here in New York and elsewhere need is to worry about a manufacturing issue that makes taking the medication even more dangerous. When a manufacturer realizes that a product is dangerous, it may issue a recall. The question is how this happens.


The FDA is responsible for oversight of many industries, including the pharmaceutical industry. When one discovers a situation that could make a drug dangerous to the public, the manufacturer is required to inform the FDA that it will be recalling it, which entails removing it from all sources from which patients could receive it.

Most often, manufacturers voluntarily issue recalls, but the FDA can force one if necessary. Other ways the FDA discovers a problem are through the receipt of consumer complaints, an FDA inspection of the facility, or an alert from the Centers for Disease Control and Prevention.

Just how serious is the danger?

The FDA places an active recall into one of the following categories:

  • If a product merely violates the FDA’s requirements for manufacturing or labeling of a drug and does not pose any significant health threats to the public, the recall receives the designation of a Class III recall.
  • If a product may cause serious harm or only causes a temporary health issue, it may fall under the designation of Class II recall.
  • If a product can cause death or serious health consequences due to the defect, it receives the status of a Class I recall.

As you can see, the higher the designation, the more life-threatening the medication is to the public.

What happens when the drug causes harm?

The news of a recall of a defective or dangerous drug does not always reach patients in time. If you suffered serious health issues, or lost a loved one, due to a defective or dangerous drug, you have rights. You may be able to receive compensation from all parties responsible for the harm done. This may include the manufacturer, distributor, and others.

Knowing who to include in a claim such as this may require some help. However, that is only the first hurdle in a case involving a dangerous drug. Cases such as these can quickly get complex and overwhelming. Big drug manufacturers often have teams of lawyers on their side. Going it alone may not be the best way to pursue the compensation, and justice, that you deserve. Fortunately, help is available.