Microbiological Hazards, Not Undeclared Allergens, Dominate United States Food Recalls: An Analysis of 24,761 Product...

Two claims dominate popular discussion of US food safety: (1) Food recalls are rising year over year, and (2) undeclared allergens have become the leading cause. In this study, we aimed to (1) test both claims against the openFDA Food Enforcement bulk export for fiscal years (FY) 2013-2025, the post-FSMA-core period following implementation of the FDA Food Safety Modernization Act (FSMA), including 24,761 conventional human-food product recall records; (2) identify the dominant microbiological hazards and undeclared allergens that drive FDA recalls; (3) compare the FDA recall record with USDA Food Safety and Inspection Service (FSIS) recalls of meat, poultry, and egg products; and (4) evaluate potential correlations between FDA and FSIS recall activity and the foodborne-illness burden recorded in CDC's National Outbreak Reporting System (NORS). Product recall records were recoded into five hazard categories using a validated 70-rule keyword scheme. Our analysis showed that annual product recall records did not increase (mean falling from 2403/yr in FY2013-2017 to 1593/yr in FY2018-2025, Welch t = 3.08, p = 0.024), and microbiological hazards were the largest category in 12 of 13 years, exceeding allergens 1.7-fold cumulatively. Listeria monocytogenes was a major driver of microbiological food recalls concentrated in fresh produce, ice cream/frozen desserts, and dairy/cheese; whereas undeclared milk was by a wide margin the most-cited allergen in food recalls concentrated in dairy/cheese, ice cream, and bakery products. Compared to FDA recalls, FSIS recalls were fewer, more severe (68.6% vs. 45.6% Class I), and allergen-led, reflecting differing inspection frameworks rather than a uniform allergen surge. Overall, food recalls and foodborne outbreak illnesses did not display a significant correlation (Spearman rho = 0.30). Classification lag shortened over the period (rho = -0.32, p < 0.001), a process-efficiency gain that can masquerade as rising recall activity in count-based trackers. Across all four objectives, the recall record describes a maturing, severity-weighted surveillance system rather than a deteriorating food supply.