Wednesday, February 26, 2025

FDA and CDC Provide Update on Listeria Outbreak Linked to Supplement Shakes

FDA and CDC provided an update on the investigation of Listeria in frozen shakes.

As of February 24, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states.   There have been 12 deaths, up one from the initial report.  Of the 38 people for whom information is available, 37 people have been hospitalized, and 12 deaths have been reported.  Age Range -  from 43 to 101 years with a median age of 78.

Case Counts
Total Illnesses: 38
Hospitalizations: 37
Deaths: 12
Last Specimen Collection Date: January 23, 2025
States with Cases: AL, CA, CO, CT, FL, IL, IN, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WA, and WV
Product Distribution: Nationwide

As summarized by CIDRAP
  • Starting in 2018, illnesses were reported but at that time, epidemiologic investigations suggested that institutional food was the likely source, however there wasn't enough evidence to pinpoint a specific food source.
  • There were subsequent investigation in 2021, and 2023, in addition to 2018.
  • The CDC reopened the investigation in October 2024 after six new infections were reported. In background information on the outbreak, the Food and Drug Administration (FDA) said 20 of the cases were reported in 2024 and 2025 and that the outbreak and the investigations are ongoing.
  • In November 2024, the FDA focused on nursing homes where many of the cases occurred. In its investigation, FDA used food invoices from involved nursing homes to show that since 2024, all nursing homes had received frozen supplement shakes from Lyons ReadyCare or Sysco Imperial brand.
  • FDA investigators used environmental sampling and whole-genome sequencing to show that the strain of Listeria found in environmental samples were closely related to isolates from sick patients.  "Three of the environmental swabs collected from the processing area tested positive for Listeria monocytogenes. Whole Genome Sequencing analysis determined that the Listeria detected in these samples is closely related to the strain of Listeria that is causing illnesses in this outbreak."
  • On February 22, Lyons Magnus, a distributor based in Fresno, California, recalled 4-ounce servings of several flavors of Lyons ReadyCare and Sysco Imperial Frozen supplemental shakes.

Center for Infectious Disease Research and Policy (CIDRAP)
https://www.cidrap.umn.edu/listeria/long-simmering-deadly-listeria-outbreak-tied-supplement-shakes
Long-simmering deadly Listeria outbreak tied to supplement shakes
Lisa Schnirring
February 25, 2025
Listeria Foodborne Disease
supplement shakes
CDC

A multistate Listeria monocytogenes outbreak that has been sickening people since 2018, 12 of them fatally, has now been tied to frozen supplement shakes consumed mainly at long-term care facilities, federal health officials said yesterday.

In a food safety alert, the Centers for Disease Control and Prevention (CDC) said 38 cases from 21 states have been reported. All but 1 patient was hospitalized.

Listeria infections can be severe or fatal, especially in pregnant women, people ages 65 and older, and those with weakened immune systems.

Earlier probes didn't turn up specific source

Though illnesses have been reported since 2018 and earlier epidemiologic investigations suggested that food served at the institutions was a likely source, there wasn't enough evidence to pinpoint a specific food source.

Following investigations in 2018, 2021, and 2023, the CDC reopened the investigation in October 2024 after six new infections were reported. In background information on the outbreak, the Food and Drug Administration (FDA) said 20 of the cases were reported in 2024 and 2025 and that the outbreak and the investigations are ongoing.

State and local health officials who interviewed sick patients found that 34 were in nursing homes or hospitals before they became ill and that 8 were on soft diets. A review of facility records showed that the supplement shakes were available to the patients.

Patient ages range from 43 to 101 years old, with a median age of 78. People who died from their infections were from California, Illinois, Indiana, Michigan, Minnesota, North Carolina, New York, Tennessee, Texas, and Washington.

Key clues from product trace-back, environmental sampling

In November 2024, the FDA said it learned that many of the sick people lived in nursing homes. Its trace-back investigation found that found that all of the nursing homes that provided food invoices since 2024 had received frozen supplement shakes from Lyons ReadyCare or Sysco Imperial brand.

FDA investigators collected environmental samples at the Prairie Farms Dairy facility that made the shakes, which were positive for the outbreak strain. Whole-genome sequencing found that bacteria from the environmental samples were closely related to isolates from sick patients.

On February 22, Lyons Magnus, a distributor based in Fresno, California, recalled 4-ounce servings of several flavors of Lyons ReadyCare and Sysco Imperial Frozen supplemental shakes.

In the company's voluntary recall notice, it said the products were made at the Prairie Farms Dairy facility in Fort Wayne, Indiana. The products were distributed throughout the United States but were not available for retail purchase.

https://www.cdc.gov/listeria/outbreaks/shakes-022025/index.html
Listeria Outbreak Linked to Supplement Shakes
February 24, 2025

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are collecting different types of data to investigate a multistate outbreak of Listeria monocytogenes infections.

Epidemiologic, laboratory, and traceback data show that supplement shakes manufactured by Prairie Farms are contaminated with Listeria and are making people sick.

Epidemiologic Data

As of February 21, 2025, 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. Sick people's samples were collected on dates ranging from August 17, 2018, to January 23, 2025. Of 38 people with information available, 37 have been hospitalized. Twelve deaths have been reported from California, Illinois, Indiana, Michigan, Minnesota, North Carolina, New York, Tennessee, Texas, and Washington. Most people in this outbreak reported living in long-term care facilities or were hospitalized prior to becoming sick.

The true number of sick people in this outbreak is likely higher than the number reported, and the outbreak may not be limited to the states with known illnesses. This is because some people recover without medical care and are not tested for Listeria. In addition, recent illnesses may not yet be reported as it usually takes 3 to 4 weeks to determine if a sick person is part of an outbreak.

Public health officials collect many different types of information from sick people, including their age, race, ethnicity, other demographics, and the foods they ate in the month before they got sick. This information provides clues to help investigators identify the source of the outbreak.

The table below has information about sick people in this outbreak ("n" is the number of people with information available for each demographic).

Demographics
Information
Age  (n=38)
Range from 43 to 101 years
Median age of 78
Sex  (n=38)
58% female
42% male
Race  (n=32)
78% White
22% African American/Black
0% Native American or Alaska Native
0% Asian
0% Native Hawaiian or other Pacific Islander
0% reported more than one race
Ethnicity  (n=31)
90% non-Hispanic
10% Hispanic

CDC investigated this outbreak in 2018, 2021, and 2023. Epidemiologic evidence in previous investigations identified that sick people were residents in long-term care facilities and nursing homes and the likely source was a food served in those types of institutions, but there was not enough information to identify a specific food. CDC reopened the investigation in October 2024 after six new illnesses were reported. In February 2025 after traceback identified a product of interest, the outbreak strain was found in environmental samples from Prairie Farms.

State and local public health officials are interviewing people about the foods they ate in the month before they got sick. Of 38 people with information, 34 (89%) reported living in long-term care facilities or were hospitalized before becoming sick. Eight people reported mechanical soft diets, like supplement shakes. Records reviewed from facilities indicated supplement shakes were available to residents.

Laboratory and Traceback Data

Public health investigators are using the PulseNet system to identify illnesses that may be part of this outbreak. CDC PulseNet manages a national database of DNA fingerprints of bacteria that cause foodborne illnesses. DNA fingerprinting is performed on bacteria using a method called whole genome sequencing (WGS). WGS showed that bacteria from sick people's samples are closely related genetically. This suggests that people in this outbreak got sick from the same food.

FDA traced food records from long-term care facilities. These records showed that supplement shakes made by Prairie Farms were a common food served to people. On February 4, 2025, FDA collected environmental samples at Prairie Farms for testing. On February 19, 2025, WGS showed that the Listeria in the environment are closely related to bacteria from sick people.
Public Health Actions
On February 22, 2025, Lyons Magnus LLC recalled supplement shakes. CDC is advising people not to eat, sell, or serve recalled products.

FDA - Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes (February 2025)
https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-frozen-supplemental-shakes-february-2025

Current Update
February 24, 2025
The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes manufactured by Prairie Farms Dairy, Inc. (“Prairie Farms”) from the Prairie Farms facility in Fort Wayne, Indiana.

On February 22, 2025, Lyons Magnus LLC recalled 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes. More information about the products being recalled is below.

As of February 24, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states. Of the 38 people for whom information is available, 37 people have been hospitalized, and 12 deaths have been reported.

As part of this investigation, FDA conducted an onsite inspection and collected environmental and product samples at Prairie Farms Dairy, Inc. in Fort Wayne, IN. Three of the environmental swabs collected from the processing area tested positive for Listeria monocytogenes. Whole Genome Sequencing analysis determined that the Listeria detected in these samples is closely related to the strain of Listeria that is causing illnesses in this outbreak.

FDA’s investigation is ongoing, and more information will be provided as it becomes available.

Case Counts
Total Illnesses: 38
Hospitalizations: 37
Deaths: 12
Last Specimen Collection Date: January 23, 2025
States with Cases: AL, CA, CO, CT, FL, IL, IN, MD, MI, MN, MO, NC, NV, NY, OH, OK, PA, TN, TX, WA, and WV

Product Distribution: Nationwide

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