Huiling Chen, Zhichun Xue, Mingzhen Yao, Zhaohan Sun, Qi Wei, Jie Li, Kunhuang Han
FDA microbiological recalls showed variation in pathogen-food category patterns and reported distribution breadth. Aggregate counts alone may obscure differences across pathogen and food categories. This structured descriptive approach may provide additional context for interpreting FDA recall activity and risk communication. Findings should be interpreted as regulatory recall patterns rather than direct measures of contamination prevalence, population exposure, disease burden, or causal risk.
BACKGROUND: Microbiological food recalls are commonly summarized by overall counts, but differences among pathogen-food category combinations remain unclear. This study characterized pathogen-food category patterns and reported nationwide distribution in U.S. Food and Drug Administration (FDA) microbiological recall records..
METHODS: We analyzed FDA food enforcement records from 2012-2024 in openFDA. Microbiological recalls were identified using predefined screening rules and classified into five pathogen and 12 food categories. Frequencies, percentages, and descriptive cross-tabulations were used to characterize pathogen-food category patterns and reported nationwide distribution.
RESULTS: Among 28,338 FDA food enforcement records, 10,824 microbiological recall records were included. Of these, 8,693 (80.3%) were Class I recalls and 1,955 (18.1%) involved reported nationwide distribution. Listeria monocytogenes and Salmonella spp. occurred across multiple food categories, whereas Clostridium botulinum was mainly associated with seafood. Food-category distributions differed across pathogen groups. Nationwide distribution was highest for Escherichia coli (34.2%), followed by Clostridium botulinum (25.0%), Salmonella spp. (20.3%), Listeria monocytogenes (15.6%), and hepatitis A virus (9.2%). Across food categories, the highest proportions of reported nationwide distribution were observed for condiments/sauces (33.1%) and dietary supplements (30.7%).
CONCLUSIONS: FDA microbiological recalls showed variation in pathogen-food category patterns and reported distribution breadth. Aggregate counts alone may obscure differences across pathogen and food categories. This structured descriptive approach may provide additional context for interpreting FDA recall activity and risk communication. Findings should be interpreted as regulatory recall patterns rather than direct measures of contamination prevalence, population exposure, disease burden, or causal risk.