About E. coli

From the nation’s leading law firm representing victims of E. coli and other foodborne illness outbreaks.

Chapter 13

E. coli Recalls

What happens when E. coli is detected in food?

When public health officials learn of potential E. coli contamination in a food product, that food is removed from the marketplace to prevent E. coli outbreaks.

Recalls of E. coli-contaminated foods are almost always voluntary; however, if a company refuses to recall its products, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) have the legal authority to detain and seize those food products in commerce.

Sometimes companies discover E. coli contamination in their products and issue E. coli-related recalls on their own. Other times, companies recall products for potential E. coli contamination if FDA or FSIS testing has revealed E. coli in a food or if FDA or FSIS has learned of a potential E. coli outbreak associated with a food.

FDA and FSIS first hear about E. coli contamination in products in several ways:

  • A company discovers a E. coli contamination in its food or facility and contacts FDA or FSIS

FDA or FSIS inspects a food-manufacturing facility and determines the potential for E. coli contamination and a recallFDA or FSIS receives reports of an E. coli outbreak associated with a particular food source through various reporting systemsThe Centers for Disease Control and Prevention (CDC) contacts FDA or FSIS to report E. coli cases associated with a food product

FDA and FSIS E. coli Recall Management

In the case of FDA-regulated products (all foods except eggs, meat and poultry), FDA’s role is to oversee a company’s E. coli recall strategy and to assess the adequacy of the recall. For USDA-regulated products, the FSIS role is well integrated into the E. coli recall process. A Recall Committee, which is housed within the FSIS Recall Management Division, makes recommendations to the company about the need for a recall if E. coli contamination is found.

Food Recall Classifications have been established for both FDA and FSIS. Guidelines are used to categorize food recalls into 1 of 3 classes, according to the level of hazard involved. In the event that pathogenic E. coli is found in a food product, a Class I recall is initiated.

FDA Recall Classifications: For all food products except meat, poultry and eggs

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin or food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

More information about FDA food recall policy can be found on the FDA Product Recall page.

USDA Recall Classifications: For all meat, poultry and egg products

Class I: This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.

Class II: This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product.

Class III: This is a situation where the use of the product will not cause adverse health consequences.

More information about USDA/FSIS food recall policy can be found on the FSIS Food Recall page.

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