FDA Guidelines for Recalls

All Practice Areas

When a product is defective or harmful to the public, the Food and Drug Administration (FDA) may order or request a recall of the product from the market. Sometimes, the manufacturers of defective products will voluntarily recall the defective product, while other recalls are ordered by the FDA.

Can the FDA Order a Recall?

The FDA does not have the authority to “order” recalls. Instead, under the Federal Food, Drug, and Cosmetic Act, the FDA may “request” the recall of a harmful consumer product if the manufacturer is unwilling to recall the product without the FDA’s written request.

FDA’s Guidelines Imposed on Companies for Product Recalls

Title 21 of the Code of Federal Regulations, Part 7 details the guidelines for companies to follow when recalling a harmful consumer product. Under these guidelines, companies are expected to:

• Develop a recall plan in case there is a need for a recall
• Notify the FDA of the recall and the starting date of the recall
• Make progress reports to the FDA
• Comply with the FDA’s request for a recall, if there is one
• Undertake subsequent checks to make sure that the recall is successful

FDA’s Role and Duties in a Recall

The only instances where the FDA will order a recall are when the recall involves a medical device, human tissue products, or infant formula. Moreover, the FDA has the authority to determine the scope and extent of these recalls. Under the guidelines outlined in Title 21 of the Code of Federal Regulations, the FDA’s role is to:

• Monitor the company recalls
• Assess the company’s actions
• Investigate the product for its defectiveness
• Make sure the product is either destroyed or reconditioned

Types of FDA Recalls

There are three types of recalls. These classes are defined by the severity of the harm it may potentially cause the general public.

• Class I – recalls dangerous or defective products that may cause serious health problems or even death
• Class II – recalls less dangerous products than Class I, that may cause only temporary health problems
• Class III – recalls products which may not cause severe health problems