High-risk food recalls in the United States: Temporal trends and structural characteristics based on FDA enforcement...

Food recalls constitute a central risk management tool within the United States food safety system; however, the distribution of recall severity-particularly high-risk Class I recalls-across temporal and structural dimensions remains insufficiently characterized.

Food recall data from the Food Enforcement Reports issued by the U.S. Food and Drug Administration (FDA) between 2012 and 2024 were analyzed. In accordance with FDA regulatory definitions, Class I recalls were treated as high-risk outcome events. Recall reasons, food categories, distribution scope, geographic region, and calendar year were systematically classified. Multivariable logistic regression models including recall reason, product category, distribution scope, geographic region, and calendar year (modeled as a categorical variable) were used to evaluate characteristics associated with Class I classification, and marginal standardization was applied to estimate adjusted temporal trends. Exploratory stratified analyses examined Class I proportions across recall reason-food category combinations and over time for the two most frequent recall reasons.

In total, 26,877 FDA-regulated food recall events were included in the analysis. Annual recall counts ranged from approximately 1,100 to more than 3,000 events per year, without evidence of a sustained monotonic trend. Microbial contamination and undeclared allergens accounted for the majority of recall events and were the predominant hazard categories associated with Class I classification. Bacterial pathogen contamination recalls generally showed high Class I proportions across major food categories, whereas undeclared allergen recalls displayed greater variation across product categories and years. Recall classification was closely aligned with hazard-related characteristics, reflecting the regulatory criteria used to define Class I recalls. Classification patterns varied across hazard types. In contrast, no consistent association was observed for distribution scope after adjustment, and associations for product categories and geographic regions were generally modest. No sustained monotonic temporal trend was identified, with substantial inter-annual variability in adjusted probabilities. Sensitivity analyses using alternative outcome definitions and restriction approaches yielded consistent results.

FDA Class I classification patterns in the United States were strongly structured by hazard characteristics, whereas associations with broader structural features, including food categories, geographic regions, and distribution scope, were generally more limited and inconsistent. Exploratory analyses showed relatively stable high Class I proportions across many bacterial pathogen-food profiles but greater variation among allergen-related recalls across product categories and calendar years. These findings characterize patterns in regulatory outcomes and may inform risk-oriented food safety management, but they do not independently establish whether individual FDA classifications were appropriate, proportionate, or scientifically justified.