Differences Among FDA Class I, II, and III Recalls

The FDA oversees certain product recalls and classifies them into three types, depending on the risk of injury to the general public.

Updated by , J.D. · University of San Francisco School of Law

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. The FDA also has jurisdiction to oversee the safety of many food items and cosmetic products.

When the FDA gets information that a certain product under its jurisdiction is defective, contaminated, or otherwise has potential negative health implications, the agency may take action to get the manufacturer to recall the item.

In most cases, recalls are voluntary. Only in rare situations does the FDA request a recall. But regardless of who initiates the recall, the FDA will categorize it into one of three classifications. Let's take a closer look at the differences between these three classes and what they can mean for a potential lawsuit.

(Check out the FDA Recalls, Market Withdrawals, & Safety Alerts page for the latest product safety information from the agency.)

Class I Recalls

A Class I recall is the most urgent and serious of the three types of FDA recalls. Class I recalls usually pertain to defective products that can cause serious health problems or death. An example would be an over-the-counter medication that has contamination from a toxin. If a Class I recall takes place, the FDA will oversee the recall process and ensure the manufacturer takes sufficient steps to protect the public.

Class II Recalls

If the FDA expects a product's defect to only result in a short-term health issue, or if there is only a slight chance it could lead to a serious problem, the FDA will designate the recall as Class II. As is the case with Class I recalls, the FDA will take an oversight role to ensure its adequacy.

Class III Recalls

Class III recalls are the least serious of the three types of FDA recalls. Class III recalls apply to minor product defects or errors that are unlikely to cause harm to someone's health.

Products Potentially Subject to an FDA Recall

FDA recalls apply to products subject to the FDA's jurisdiction. Besides drugs, foods, and cosmetics, an FDA Recall can also apply to:

  • vaccines
  • human tissue used for transplantation
  • human blood and blood products, and
  • medical devices.

How an FDA Recall Can Affect a Lawsuit

Some FDA recalls may apply to products that result in lawsuits for injury or economic harm to a consumer or patient. An economic injury usually refers to the money a plaintiff spent on the item.

For instance, if an infant's toy turns out to pose a choking risk to children under three, the parents can sue for economic damages. But as long as the product doesn't harm the child, there can be no recovery of personal injury damages. The parents could potentially sue to get their money back, but most toys don't cost enough to warrant a lawsuit for a refund. That's why these types of economic harm cases affecting many people commonly exist only as class action lawsuits.

But note that when a company initiates a recall, it can make it harder for a group of affected consumers to sue as a class. That's because some recalls establish a procedure through which consumers can request a full refund, and if the purchase price represents the extent of the consumer's damages, there's nothing left to sue for.

In a product liability lawsuit involving personal injuries, while a recall doesn't automatically immunize the defendant, it can make it harder for a plaintiff to succeed. This is especially true if the plaintiff purchased the product or continued to use it after the recall occurred.

But simply recalling a product does not guarantee a defendant wins the case. The defendant must also show that it provided adequate notice of the recall to consumers. Learn more about a manufacturer's defenses to a product liability lawsuit.

If your use of a recalled product resulted in an injury, you might want to discuss the situation (and your legal options) with a personal injury lawyer.

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