As a previous post highlighted, when it is discovered that a product could pose dangers to consumers, a recall is issued. When a defective product could cause consumers in Montana and elsewhere in the US harm, the product needs to be removed from the market. In order to do this properly and effectively, a product has to go through the recall process. This ensures that all items are removed and corrective measures are taken.

If a product is FDA-regulated and is recalled, then it goes through a recall process designated by the FDA. The FDA regulated products, such as human drugs, animal drugs, medical devices, radiation-emitting products, vaccines, blood and blood products, transplantable human tissue, animal feed, cosmetics, tobacco and about 80 percent of the food consumed in the United States.

The FDA’s definition of a recall is the firm removal or correction of a marketed product that the FDA believes to be in violation of the laws it administers. A recall is conducted by those responsible for the recalled product’s manufacture and distribution. Removal has various definitions and does not just mean taking a product off of the market. It could also mean taking corrective measures or destroying the product without moving the product to another location.

While most recalls are conducted on a voluntary basis, there are some situations where the FDA initiates them or orders them, if it is determined by the FDA that a specific product poses a risk. Recently, the FDA was provided the authority to recall food when there is a reasonable probability that it has been altered, misbranded or exposed to an article that could cause serious adverse health consequences.

Once a FDA-regulated product is recalled or a company intends to initiate a recall, they must report this to the FDA. The FDA then advises on the best strategy for recall. This includes evaluating the risks posed by the product and classifying the recall. Once the recall is initiated, the FDA will monitor and audit it until it is complete.

The above information is just a brief explanation of the FDA-regulate product recall. The process can become more complex and could involve more steps. Additionally, consumers that have been harmed prior to, during and after a recall should understand that they might have recourses available to them. This is often dependent on the timing and effectiveness of the recall. An injured consumer might be able to collect compensation through a products liability lawsuit, helping them offset damages and losses caused by a defective or dangerous product.

Source:, “Recall Process for FDA-Regulated Products,” accessed on May 2, 2016