Overview of FDA Recalls of Products

FDA recalls can be alarming. If you have a product that has been recalled, it’s important to understand what that means for you and your family.

What is an FDA Recall?

A recall is an action taken to remove a product from the market that is defective or potentially harmful to the public.

The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. It also oversees the regulation and safety of many food items and cosmetic products.

When the FDA considers a product on the market to be in violation of its regulations, the FDA may issue a recall to remove the product or correct the defect. The defect may be in the product itself, in the product labeling, or in promotional literature for the product.

How does the FDA recall products?

There are three types of FDA recalls which dictate how a product is recalled:

1. Voluntary: The majority of recalls fall in this category. This type of recall is initiated by manufacturers themselves to protect the public from risk of injury. This type of recall also includes instances where the FDA notices a problem with a product and gives the manufacturer a chance to withdraw the product on its own without further FDA intervention.
2. FDA Requested: This type of recall is issued when the FDA realizes a product to be in violation of its regulations but mandatory legal recall authority does not exist. In this case, the manufacturer does not initiate a recall on its own. This type of recall is normally reserved for urgent situations and with products whose continued use may cause serious death or injury. Examples include problems with pacemakers and life-saving drugs.
3. FDA Mandated: When certain products are involved, statutes give the FDA has legal authority to automatically order a recall. Products include food, infant formula, medical devices whose use will likely cause death, tobacco products, controlled substances and biological products.

How do I know how dangerous a recalled product is?

There are three recall classifications. Each one indicates the degree of health hazard presented by the recalled product. The classifications determine how notice is given to the public.

1. Class I: Recalls for products which may cause serious injury or death. For example, a label mix-up on a life saving drug falls in this class.
2. Class II: Recalls for products which might cause serious injury or temporary illness. For example, most medical implants fall in this class. Another example is a drug that is under strength but is not used for life threatening situations.
3. Class III: Recalls for products which are unlikely to cause injury or illness but that violate FDA regulations. An example is a minor defect in product packaging.

Information on recalled products is available online at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts 

If you or a a loved one has been injured by a recalled medical device or medicine, our firm may be able to help you. Contact us for a free consultation at 504-593-9600.