FDA Responded to 26 Foodborne Illness Outbreaks in 2025
Need to Know
- FDA CORE+EP evaluated 69 incidents, initiated 26 outbreak responses, and issued 11 public health advisories in 2025
- Foods implicated in 2025 investigations included eggs, cucumbers, prepared pasta meals, frozen supplemental shakes, powdered infant formula, pistachio cream, sprouts, and moringa leaf
- Four investigations highlighted key outbreak-response lessons: continued post-outbreak sampling helped detect a cucumber-related Salmonella outbreak; new evidence solved a longstanding Listeria outbreak; interagency traceback identified Listeria-contaminated pasta; and the first known U.S. infant botulism outbreak associated with formula was recorded
- CORE+EP’s responsibilities have expanded beyond outbreak response to food defense, traceability, and supply chain management
- FDA introduced new post-outbreak transparency and prevention resources in 2025, including EIS Abstracts and FOOD Reports
The U.S. Food and Drug Administration’s (FDA’s) Office of Coordinated Outbreak Response, Evaluation, and Emergency Preparedness (CORE+EP) has published its 2025 Annual Report, summarizing CORE+EP’s response to outbreaks and certain adverse events associated with FDA-regulated human foods, notable outbreaks that occurred, and details of the office’s expanded responsibilities for food defense, traceability, and supply chain management.
FDA CORE+EP's 2025 Outbreak Response by the Numbers
In 2025, FDA’s CORE+EP took the following actions (which can include activities spanning multiple years, not just those beginning and ending within the calendar year):
- Evaluated 69 incidents: The CORE Signals and Surveillance Team evaluated potential outbreaks, confirmed outbreaks, and certain adverse events
- Initiated 26 responses: When available evidence suggested that an outbreak was caused by an FDA-regulated food, the incident was transferred to one of four CORE Response Teams to coordinate FDA's response
- Issued 11 public health advisories: FDA issued advisories when an FDA-regulated food linked to an outbreak warranted actionable advice for consumers.
Not every incident evaluated by the Signals Team was transferred to an FDA Response Team. For example, outbreaks associated with foods regulated by the U.S. Department of Agriculture (USDA) were referred to the appropriate regulatory agency. Additionally, not every incident transferred to a Response Team resulted in an advisory, such as when investigators did not identify a food vehicle during an active outbreak or when no specific consumer action was necessary. An article written by FDA CORE+EP authors for Food Safety Magazine explains the Signals Team’s role in CORE+EP and how it detects signals and triages incidents.
Foods Linked to Illnesses in 2025
Products identified in CORE responses during 2025, aligned with U.S. Interagency Food Safety Analytics Collaboration (IFSAC) criteria, included:
- Multi-ingredient foods: Frozen supplemental shakes, prepared pasta meals, pistachio cream, ready-to-eat foods, and mini pastries
- Shell eggs: Eggs were implicated in two distinct outbreaks
- Dairy, solid/semi-solid products: Powdered infant formula
- Fruits: Mangoes
- Vegetables: Cucumbers, frozen sprouted beans, cilantro, parsley, spring mix, and sprouts
- Other: Moringa leaf.
For several investigations involving mangoes, cilantro, parsley, spring mix, and sprouts that were linked to illnesses, FDA did not issue public health advisories, typically because sufficient information about the cause of illnesses was unavailable while an ongoing public health risk existed.
Recalls, Warning Letters, and Import Alerts
CORE investigations supported a range of public health and regulatory actions in 2025. When investigators identified a food source associated with a multistate outbreak, actions could include public health advisories and voluntary recalls. FDA's Office of Compliance and Enforcement could also pursue measures such as warning letters, seizures, injunctions, and import alerts.
The 11 outbreaks for which FDA issued public health advisories involved:
- Salmonella Enteritidis linked to mini pastries
- L. monocytogenes linked to frozen supplemental shakes
- L. monocytogenes linked to ready-to-eat foods
- Salmonella Montevideo linked to cucumbers
- Two Salmonella Enteritidis outbreaks linked to eggs, ending in July and November
- Salmonella Oranienburg linked to pistachio cream
- L. monocytogenes linked to prepared pasta meals
- Salmonella Anatum linked to frozen sprouted bean products
- Salmonella Richmond linked to moringa leaf powder
- Infant botulism linked to powdered infant formula.
Actions associated with these investigations included recalls, import alerts, and warning letters. FDA noted that outbreak investigations also informed follow-up inspections, continued risk assessments, prevention strategies, and other post-response work.
Noteworthy Foodborne Illness Outbreak Investigations in 2025
FDA highlighted four outbreak investigations that demonstrated important aspects of CORE+EP's surveillance, traceback, sampling, and response work in 2025:
- Salmonella Montevideo linked to cucumbers: A routine follow-up inspection and sampling at a grower associated with a 2024 cucumber outbreak detected Salmonella Montevideo that matched clinical isolates by whole genome sequencing (WGS), allowing FDA and its partners to begin investigating the 2025 outbreak based on early laboratory evidence. FDA pointed to the investigation as an example of the value of continued sampling and surveillance following an outbreak.
- Listeria monocytogenes linked to frozen supplemental shakes: Investigators solved a longstanding outbreak dating to 2018 that primarily affected people in long-term care facilities. New traceback information, historical illness data, updated epidemiological evidence, and laboratory findings from an FDA inspection enabled investigators to identify frozen supplemental shakes as the source, demonstrating the value of revisiting unresolved outbreaks as new evidence emerges.
- Listeria monocytogenes linked to prepared pasta meals: The complex, dual-jurisdiction investigation required FDA and USDA's Food Safety and Inspection Service (USDA-FSIS) to trace different components of prepared meals through the supply chain. FDA eventually narrowed its investigation to pasta manufactured by Nate's Fine Food LLC. FDA highlighted the investigation as an example of the extensive coordination that can be required among federal agencies, state and local partners, and industry to identify an outbreak source.
- Infant botulism linked to powdered infant formula: FDA described the incident as the first known U.S. infant botulism outbreak associated with infant formula. Investigators detected Clostridium botulinum in finished ByHeart Nutrition formula and a powdered milk ingredient, with WGS linking samples from one lot of organic whole milk powder to a clinical sample and a sample from an unopened can of formula. FDA has not determined the outbreak's root cause and has continued post-incident and root-cause investigation activities, including work supporting a risk assessment for C. botulinum in infant formula.
CORE+EP Expands Work on Food Defense, Traceability
The 2025 report also reflected CORE+EP's responsibilities beyond acute outbreak and adverse event response. Beginning in October 2024, the office took on increased responsibilities involving food defense, traceability, and supply chain management.
In support of FDA's Food Safety Modernization Act (FSMA) Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration, the CORE+EP Food Defense Team:
- Provided subject-matter expertise for 66 domestic and one foreign comprehensive food defense inspections
- Deployed enhancements to a system used by FDA Food Defense Branch investigators during inspections.
Across the office, CORE+EP personnel also helped respond to more than 300 Food Traceability Rule Technical Assistance Network inquiries and dozens of inquiries involving the Intentional Adulteration Rule.
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Post-Outbreak Transparency Efforts
CORE+EP also introduced new tools in 2025 intended to share findings and lessons from foodborne illness investigations.
FDA launched Executive Incident Summary (EIS) Abstracts, which provide high-level, redacted summaries of actions taken during investigations managed by CORE Response Teams. The abstracts are intended to supplement FDA's existing outbreak communications while highlighting the contributions of federal, state, and local partners.
CORE+EP also published two Foodborne Outbreak Overview of Data (FOOD) Reports in 2025. FOOD Reports examine food-pathogen pairs repeatedly associated with outbreaks and incorporate:
- Historical epidemiological information
- Laboratory analyses
- Traceback and investigation findings
- Post-response prevention activities.
FDA said the ongoing report series is intended to provide information that could support efforts to prevent future foodborne illnesses.
Lessons from FDA CORE+EP Outbreak Publications and Reports in 2025
Complementing the newly published CORE+EP 2025 Annual Report, in September 2026, Food Safety Magazine published an article authored by FDA CORE+EP scientists, titled, "Lessons Learned from Outbreaks: Publications and Reports from FDA's CORE+EP in FY 2025."
The article outlined and analyzed 15 publications with CORE+EP contributions during fiscal year 2025, covering outbreaks associated with leafy greens, melons, fishery products, enoki mushrooms, peaches, strawberries, peanut butter, alfalfa sprouts, and diced onions, as well as research on emerging chemical hazards, novel outbreak surveillance data streams, and foodborne illness attribution using WGS.
The publications “highlight the contribution of the CORE+EP staff and its partners to current science, examining the distribution and causes of foodborne outbreaks and improving methods to identify and prevent future occurrences,” wrote the authors.
