Difference Between FDA Class I, II, and III Recalls

The three classes of FDA product recalls are ordered by the degree of risk of injury to the public.

The U.S. Food and Drug Administration (FDA) is the branch of the federal government that is responsible for overseeing the regulation and safety of prescription and over-the-counter drugs, as well as most cosmetic products, and even some food items. When the FDA gets information that a certain product under their jurisdiction is defective or contaminated, or otherwise has potential negative health implications, the agency may issue a public recall of that item. There are three main types of FDA recalls, and we'll take a closer look at the different classifications in the sections below.

An FDA "Class I Recall" is the most urgent type of recall that the FDA will issue.

In an FDA Class I Recall, there is significant and immediate danger of death or other serious injury from the use of the product being recalled. Class I recalls are pretty rare, but they should be obeyed as soon as you become aware of them. In the case of Class I Recall, the FDA will develop an individual plan that is specific to the manufacturer and the product involved, to make sure that compliance with the recall is complete and that the recall of the items involved is trackable. The objective here is to be sure that all of the affected items are removed from the market, and from people's homes.

An FDA "Class II Recall" is an intermediate threat level recall.

A Class II recall is issued where there is no immediate danger of death or other serious injury linked to the product, but the risk of death or a serious injury is still present. A Class II recall is more preventative in nature, but there are still health and safety risks involved. As in a Class I recall, the FDA will work with the manufacturer to help get the word out about the recall, as well as to create a plan to make sure that all of the recalled items are pulled from the market as quickly as possible.

An FDA "Class III Recall" is the least serious of all recalls.

A Class II recall is typically issued where there is no immediate or perceived danger of any health issues, but where items have been released that are in violation of FDA regulations. An example of a Class III Recall is the 2010 recall of children’s medicines that were potentially contaminated with small pieces of plastic during the manufacturing process.

Legal Claims Over Defective Products

In some cases, a drug or some other product (whether or not it is the subject of a recall) can cause an injury to a consumer. This can happen when the product makes it to the market despite a manufacturing defect, when use of the product comes with unexpected and unforeseeable risks, or when the manufacturer failed to take proper steps to warn consumers of health and safety risks that could come from the product's use. To learn more about defective products and injury liability, see Alllaw's section on dangerous product claims.

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