Product recalls are an unwelcome event among food manufacturers. In recent years, recalls for undeclared allergens have become the number-one reason for food product recalls. Often, the U.S. Food and Drug Administration (FDA) and/or the U.S. Department of Agriculture's Food Safety and Inspection Service (USDA-FSIS) classify recalls for undeclared allergens as Class 1 recalls because the products contain residues of undeclared priority food allergens that have been associated with severe allergic reactions, including fatalities.
Class 1 recalls are defined as situations where there is a reasonable probability that the use of or exposure to a food product will cause serious adverse health consequences or death to humans. Residues of most of the so-called "Big 8" (and soon-to-be "Big 9," with the recent addition of sesame seeds) allergenic foods are considered as a basis for Class 1 recalls. The Big 8 allergenic foods are milk, eggs, fish, crustacean shellfish (e.g., shrimp, crab, lobster), peanuts, soybeans, tree nuts (walnuts, cashews, etc.), and wheat. Residues of these Big 8 priority allergenic foods are almost always considered as a basis for Class 1 recalls.