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NewsContamination ControlRegulatoryMicrobiologicalFDA

FDA Reveals Unsolved E. Coli Outbreak in New Foodborne Illness Outbreak Transparency Tools

By Food Safety Magazine Editorial Team
cucumbers sandwiches eggs
Image(s) credit: Freepik
September 25, 2025

The U.S. Food and Drug Administration (FDA) has introduced two resources aimed at improving public access to information following the conclusion of foodborne illness outbreak investigations: Executive Incident Summary (EIS) Abstracts for closed investigations and Foodborne Outbreak Overview of Data (FOOD) Reports.

The tools are designed to provide stakeholders—including industry, government agencies, and consumers—with timely and relevant information that may support efforts to prevent future outbreaks.

EIS Abstracts Reveal Previously Undisclosed, Unsolved E. coli Outbreak

EIS abstracts offer a high-level overview of completed outbreak or adverse event investigations involving FDA-regulated human food products. Developed after the response phase has ended, the summaries include traceback, laboratory, and epidemiological data. They are redacted in accordance with federal disclosure laws and FDA regulations to protect confidential and personally identifiable information. EIS abstracts are available on the CORE Investigations Table and a dedicated EIS landing page.

At present, there are four EIS abstracts available, including an abstract for an outbreak that had previously not been communicated to the public:

  • April 2025 outbreak of Listeria monocytogenes with suspected link to ready-to-eat (RTE) deli sandwiches produced by Fresh and Ready Foods LLC. All ten patients included in the outbreak were hospitalized, and one person died. Patients were identified in two states (California and Nevada). FDA conducted an inspection and sampling at Fresh and Ready Foods' San Fernando, California facility. The two environmental samples and recent 2025 clinical isolate were genetically related to historical 2024 outbreak clinical isolates, and three patients were hospitalized prior to onset of illness at hospitals that served Fresh and Ready Foods sandwiches. Still, there was no sufficient epidemiologic and traceback evidence to definitively confirm the outbreak vehicle. FDA issued a Form 483 to Fresh and Ready Foods, and the company initiated a voluntary product recall.
  • April 2025 outbreak of Salmonella linked to shell eggs sourced from August Egg Company of Turlock, California, which sickened 134 people in ten states, resulting in 38 hospitalizations and one death. Whole genome sequencing (WGS) analysis revealed the clinical isolates to be genetically related to product and environmental isolates from August Egg Company. Traceback activities also implicated August Egg Company as the supplier. FDA did not issue Form 483s as a result of its inspections of August Egg Company, and a source of contamination was unable to be identified. August Egg Company initiated a voluntary recall.
  • April 2025 outbreak of Escherichia coli O145:H28 with an unidentified source, which sickened 11 people in a redacted number of states, causing three hospitalizations, one case of hemolytic uremic syndrome (HUS), and one death. WGS data connected the 11 cases. FDA did not issue any public communications about this outbreak prior to the publication of this EIS abstract. FDA initiated traceback record collection and inspections at redacted firms, as well as environmental and retail sampling. However, no firms were implicated in the traceback investigation due to limited purchase information and lack of commonalities for the component ingredients used in the redacted product. The outbreak investigation did not yield sufficient evidence to identify a definitive source or route of contamination. Although epidemiologic data were suggestive, the absence of supporting laboratory, traceback, and inspectional evidence limited the ability to confirm the redacted food as the vehicle.
  • May 2025 outbreak of Salmonella linked to cucumbers supplied by Bedner Growers Inc. of Boynton Beach, Florida. A total of 69 people were sickened in 21 states, including 22 hospitalizations and one death. FDA was initially alerted to the outbreak when WGS data for a Salmonella-positive swab from Bedner Growers matched WGS data for two clinical isolates. Traceback found Bedner Growers to be the supplier of the cucumbers for all cases included in the investigation. Sampling of cucumbers sourced from Bedner Growers at a distribution center in Pennsylvania found Salmonella isolates genetically related to clinical isolates. WGS also matched environmental Salmonella isolates from Bedner Growers to clinical isolates from a 2024 salmonellosis outbreak. Bedner Growers issued a voluntary recall.

FOOD Reports Dive Deep into Berry Hepatitis A Outbreaks, Tahini Salmonella Outbreaks

FOOD Reports provide retrospective analyses of recurring pathogen-commodity pairs linked to foodborne illness. Each report includes historical data, laboratory findings, traceback results, and prevention activities undertaken by various stakeholders. The initial reports released summarize hepatitis A outbreaks associated with berries and Salmonella outbreaks linked to tahini.

The reports include background on the food-pathogen pairs, including outbreak history; CORE outbreak data analyses; historical inspections, events, and actions; and post-response analyses.

The resources are intended to support data-driven decision-making and enhance food safety communication, training, and research. FDA uses findings from these investigations to inform priorities and guide resource allocation for prevention efforts.

The agency continues to collaborate with industry, academia, and regulatory partners to identify root causes and develop strategies to mitigate risks. Recent initiatives include a strategy to prevent viral contamination of berries and ongoing engagement around tahini safety through technical meetings and scientific publications.

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KEYWORDS: foodborne illness outbreak investigations report

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The Food Safety Magazine editorial team comprises Bailee Henderson, Digital Editor ✉; Adrienne Blume, M.A., Editorial Director; and Stacy Atchison, Publisher.

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