FDA's 2025 Outbreak Report: 69 Incidents, 11 Advisories

The Food and Drug Administration's Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP) released its 2025 annual report on October 6, 2026. In 2025, CORE teams evaluated 69 incidents, responded to 26 and issued advisories for 11. The report covers outbreaks and adverse events in FDA-regulated foods, and the actions that followed: recalls, warning letters and import alerts.

Key takeaways:

• On October 6, 2026, FDA CORE+EP released its 2025 annual report covering 69 evaluated food safety incidents, 26 outbreak responses, and 11 public health advisories.
• Noteworthy cases include Salmonella linked to cucumbers from a Florida grower, a Listeria outbreak dating to 2018 linked to frozen supplemental shakes, and what FDA calls the first known infant botulism outbreak in the U.S. tied to infant formula.
• FDA issued warning letters to Walmart, Target, Kroger and Albertsons "for continuing to sell recalled infant formula weeks after the nationwide recall had been announced."
• Responses involving mangoes, cilantro, parsley, spring mix and sprouts linked a product, but no advisory was issued.
• FDA "has not yet determined the root cause(s)" of the infant botulism outbreak.

What happened

On October 6, 2026, the FDA published the CORE+EP 2025 Annual Report detailing investigations into foodborne illness outbreaks and adverse events in FDA-regulated foods throughout the 2025 calendar year. The office, led by Director Dr. Stic Harris, was originally established in 2011 as the CORE Network and expanded in October 2024 to integrate food defense, traceability, and supply chain monitoring into its outbreak workflow.

According to the FDA constituent update published alongside the report, CORE teams evaluated 69 incidents, responded to 26, and issued advisories for 11. FDA says these numbers "remain similar to those from previous years, with 72 incidents evaluated, 26 responses, and 10 advisories issued in 2024."

The report notes: "Not all incidents transferred to a Response Team result in an advisory being issued. In most cases, this is because a vehicle is not identified while the outbreak is ongoing." Current outbreak investigations are listed on FDA's Investigations of Foodborne Illness Outbreaks live tracking table.

What changed

The report's actions table pairs each 2025 advisory with the recalls and other enforcement that followed, across Salmonella, Listeria and infant botulism responses.

Enforcement actions highlighted in the report table include:

• Salmonella Enteritidis in mini pastries, resulting in an advisory, recall, and Import Alert 99-19.
• Listeria monocytogenes in frozen supplemental shakes, with an advisory and recall.
• Listeria monocytogenes in ready-to-eat foods, with an advisory, recall and a warning letter.
• Salmonella Montevideo in fresh cucumbers, accompanied by an advisory, recall, and an agency warning letter.
• Salmonella Enteritidis in shell eggs, in two distinct outbreaks, each with an advisory and recall.
• Salmonella Oranienburg in pistachio cream, which triggered an advisory, recall, and Import Alert 99-43.
• Listeria monocytogenes in prepared pasta meals, with an advisory and recall.
• Salmonella Anatum in Deep-brand frozen sprouted beans, leading to an advisory, recall, and Import Alert 99-43.
• Salmonella Richmond in moringa powder, leading to an advisory and recall.
• Infant botulism tied to powdered infant formula, with an advisory, recall, warning letters to Target, Albertsons, Kroger and Walmart, and a letter to industry.

Beyond direct pathogen tracking, CORE+EP operationalized broader monitoring responsibilities in 2025. The food defense group provided technical input on 66 domestic food defense inspections and one foreign inspection. Staff answered "over 300 Food Traceability Rule Technical Assistance Network inquiries," and the office launched Executive Incident Summary (EIS) Abstracts and two Foodborne Outbreak Overview of Data (FOOD) Reports.

Who is affected

Products linked to 2025 responses, grouped by the report into Interagency Food Safety Analytics Collaboration (IFSAC) categories, were frozen shakes, prepared pasta meals, pistachio cream, ready-to-eat foods, mini pastries, shell eggs (two distinct outbreaks), powdered infant formula, mangoes, cucumbers, frozen sprouted beans, cilantro, parsley, spring mix, sprouts and moringa leaf. The report excludes meat and poultry regulated by USDA's Food Safety and Inspection Service (FSIS).

The report highlights four noteworthy investigations:

1. Cucumbers: A Salmonella Montevideo outbreak was linked to cucumbers through an FDA environmental sample taken in April 2025 at Bedner Growers, Inc., in Boynton Beach, Florida, which matched ill people by whole genome sequencing (WGS). The report says "the 2025 outbreak was significantly smaller than the 2024 outbreak (69 cases in 2025 versus 551 cases in 2024)"; the 2024 outbreak "ended with 551 illnesses in 34 states and the District of Columbia." Bedner Growers received a warning letter.

2. Frozen Supplemental Shakes: A Listeria monocytogenes outbreak dating to 2018 mostly affected residents of long-term care facilities. The contamination was linked to Lyons ReadyCare and Sysco Imperial frozen supplemental shakes manufactured at Prairie Farms Dairy, Inc., in Fort Wayne, Indiana, and recalled by Lyons Magnus LLC. The report counts "42 sick people from 21 states, 41 hospitalizations, and 14 deaths."

3. Powdered Infant Formula: The outbreak involved ByHeart Whole Nutrition Infant Formula. Among cases with confirmatory testing, "eight illnesses were confirmed to be caused by botulinum toxin type A." Clostridium botulinum was found in a powdered milk ingredient and in finished product: two samples of one lot of organic whole milk powder (Dairy Farmers of America, processor for Organic West Milk) matched a clinical sample and a closed formula sample. The recall began November 8, 2025 and was expanded on November 11, 2025 to all ByHeart formula. WGS found 17 different strains, and CDC declared the outbreak over on February 26, 2026. FDA says: "This is the first known infant botulism outbreak in the U.S. tied to infant formula."

4. Prepared Pasta Meals: In March 2025, FSIS found Listeria monocytogenes in chicken fettuccine alfredo meals, and FDA traced it to pasta made by Nate's Fine Food, LLC.

The report marks the mango, cilantro, parsley, spring mix and sprouts responses as ones where a product was linked but "no Advisory was issued"; it does not detail those outbreaks further. For 2026 outbreaks that are not in this 2025 report, see FDA Finds Cyclospora at Mexico Lettuce Sites, Closes Probe and the Jalapeño Salmonella Outbreak Declared Over at 488 Cases.

What it means for shoppers

The report is a look back at 2025, not a new recall. Its most shopper-relevant detail concerns retail follow-through: on December 12, 2025, FDA sent warning letters to Walmart, Target, Kroger and Albertsons "for continuing to sell recalled infant formula weeks after the nationwide recall had been announced."

The report gives no new consumer advice. Product-specific recall details, including lot codes, are in each FDA recall notice, and open investigations are on FDA's outbreak table linked above.

The background

The report covers outbreaks and adverse events in FDA-regulated foods only; meat and poultry outbreaks handled by FSIS are outside its scope. It also has limits. It does not give the aggregate number of total illnesses, hospitalizations, or deaths across all 2025 FDA investigations combined, publishing figures only for select major outbreaks. It also gives no illness counts for the egg, pistachio cream, mini pastry, moringa powder, or sprouted bean responses, and it does not detail the responses where no advisory was issued. And FDA "has not yet determined the root cause(s)" of the ByHeart infant botulism outbreak.

What to watch next

The report covers calendar year 2025 only; 2026 outbreaks are not included. Further FDA findings on the infant botulism root cause, if published, would be the main follow-up to watch.

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