Mandatory Recall
A recall ordered by the FDA when a company refuses to voluntarily recall a product that poses a health risk.
What It Means
A mandatory recall is a recall ordered directly by the FDA when a company refuses to voluntarily recall a product that the agency has determined is adulterated or misbranded and poses a risk to public health. The FDA gained the authority to issue mandatory food recalls through the FDA Food Safety Modernization Act (FSMA), signed into law in 2011. Prior to FSMA, the FDA could only request that companies voluntarily recall products and had limited enforcement options if a company refused. Under Section 206 of FSMA, the FDA can order a mandatory recall if it determines that there is a reasonable probability that a food is adulterated or misbranded and that the use of or exposure to the food will cause serious adverse health consequences or death. Before issuing a mandatory recall order, the FDA must provide the company an opportunity to voluntarily recall the product. Mandatory recalls are extremely rare in practice because companies almost always comply with FDA requests for voluntary recalls. The existence of mandatory recall authority, however, serves as an important backstop that strengthens the FDA's ability to protect public health. When a mandatory recall is ordered, the company must immediately cease distribution of the product and notify all persons in the distribution chain.
Related Terms
Voluntary Recall
A recall initiated by the food manufacturer or distributor on their own, without an FDA order.
FDA Food Recall
A voluntary or mandatory action by a firm to remove a food product from the market when it may be unsafe or mislabeled.
FSMA (Food Safety Modernization Act)
The landmark 2011 law that shifted FDA food regulation from reacting to contamination to preventing it.
Frequently Asked Questions
What does Mandatory Recall mean?
A recall ordered by the FDA when a company refuses to voluntarily recall a product that poses a health risk.
Why is Mandatory Recall important for food safety?
A mandatory recall is a recall ordered directly by the FDA when a company refuses to voluntarily recall a product that the agency has determined is adulterated or misbranded and poses a risk to public health. The FDA gained the authority to issue mandatory food recalls through the FDA Food Safety Mo...