Food Safety Guidelines: Voluntary Product Recall vs. Mandatory Recall

Food Safety Guidelines: Voluntary Product Recall vs. Mandatory Recall

May 2, 2017

Ellis Law Corporation

Defective Products

If food and food products become unsafe, they can be withdrawn from the market either by voluntary recalls or via a mandatory recall issued by the Federal government. But what’s the difference between the two?

Simply put, a voluntary recall can be effected by either the company which made the product or U.S. regulatory authorities. A mandatory recall is issued by the U.S. government.

Both types of recalls depend on receiving reports from affected citizens or businesses.

Recalls by the U.S. government: degree of public risk at issue

The U.S. Food and Drug Administration (FDA) has the authority to regulate the safety of medical devices, prescriptions, and some foods. Other government authorities, such as the U.S. Department of Agriculture (USDA), are responsible for food safety as well.

If food becomes unsafe for the public, the U.S. Food and Drug Administration (FDA) has the authority to issue either a voluntary product recall or a mandatory recall.

There are three stages of FDA recall. The demarcation between them is the amount of public risk the food poses. The stages are:

Class I Recall – Immediate and Significant Danger of Death or Injury

The Class I recall means that the FDA has determined there to be a significant and immediate danger of death or serious injury from using the product. In a Class I Recall, the FDA issues a plan for the manufacturer to completely recall the product. The plan needs to be trackable, to ensure that all stores and other sales sites have eliminated the product from inventory and that purchasers have been alerted to stop using the product and get it out of their homes.

Class II Recall – Risk of Death or Serious Injury

A Class II recall means that risk of death or serious injury from the product exists, but it is not immediate. As in Class I, the FDA issues a plan for the manufacturer and consumers.

Class III Recall – Products Available That Violate FDA Regulations

A Class III recall is issued when danger is not imminent or there may not be health-related concerns, but products are available that are in violation of FDA regulations. In 2010, for example, the FDA issued a Class III recall of a children’s medication whose production process had led to plastic in the bottles. While not food, it illustrates the scope of a Class III recall.

Generally, the FDA issues recall plans and stipulations and relies on responsible parties — the product manufacturers, stores, and suppliers, among others — to comply with the plan. However, if they do not comply, the FDA has the authority to issue a mandatory recall.

Food recalls by a company

Companies who receive reports that their products are causing danger, ill effects, or death among the public can also put a voluntary recall plan into effect. They can also voluntarily recall products if they discover defects in the processes used to develop or manufacture the product, before or after it is shipped to outlets.

Essentially, there are two types of company-initiated recalls. The first is termed “market withdrawal.” This can be done if a product does not violate FDA regulations, but is unsafe. The company both removes any outstanding product on the market and fixes any violation.

The second is recall done by the firm itself. This may be done if the company, for example, realizes a product poses danger and moves to eliminate the danger before the FDA issues a recall.

Companies also undergo product recalls in conjunction with an FDA plan, under the three classifications discussed above.

Types of recalls can change according to circumstances. In the 2013 case of Chobani yogurt, for example, the product was determined to have a type of mold that had the potential to make people sick. Chobani first used a market withdrawal, and then moved to a recall.

Talk to a product liability attorney today

Ellis Law Firm has been protecting people’s rights from corporations in southern California for more than 20 years. If you or a loved one has been harmed by a food or by food-borne illness because a food was manufactured or sold unsafely, we can help.

Call us today to discuss product liability or negligence. Your consultation with an experienced and knowledgeable product liability lawyer comes at no charge to you. Call 310-641-3335 today.

Additional California food recall resources:

  1. “FDA Publishes Draft Guidance on Mandatory Recall Authority.” Food Safety News. May 7, 2015.
  2. Recalls and Alerts.
  3. U.S. Food and Drug Administration. FDA Basics. “What Is a Recall?”