Recalls Associated with Food Allergens and Gluten in FDA-Regulated Foods from Fiscal Years 2013 to 2019.

Allergens are one of the leading causes of food recalls in the US. The Food and Drug Administration (FDA) enforces requirements relating to major food allergens (MFAs) and gluten-free labeling to ensure food safety for allergic and celiac patients, respectively. Violative foods are subject to recalls. In this study, recall data for FDA-regulated foods were analyzed for fiscal years (FYs) 2013-2019 to identify trends and root causes associated with 1471 food allergen and gluten recalls. Of the 1471 recalls, 1415 recalls were due to MFAs, 34 recalls were due to gluten-free labeling violation and 23 recalls involved other allergens. Recalls due to MFAs overall increased during the study period with a peak incidence in FY 2017. MFA recall health hazard classifications were assessed as Class I (51.2%), Class II (45.5%), and Class III (3.3%). A majority of MFA recalls involved one allergen (78.8%). Milk was the most common MFA involved in MFA recalls (37.5%), followed by soy (22.5%) and tree nuts (21.6%). Almond, anchovy, and shrimp were the most common allergens recalled within the MFA groups of tree nuts, fish, and Crustacean shellfish, respectively. About 97% of MFA recalls involved one product category and among them, the category of 'bakery products, dough, bakery mixes and icings' ranked first (367 recalls), followed by the category of 'chocolate and cocoa products' (120 recalls). Labeling-associated errors accounted for 71.1% of MFA recalls with known root causes (914 out of 1286). It is important for the industry to develop and implement appropriate allergen controls to reduce the number of MFA recalls.