The US Food and Drug Administration (FDA) has issued a nationwide recall of frozen supplemental shakes after they were linked to a Listeria monocytogenes outbreak that has caused 11 deaths and 38 illnesses across 21 states. The shakes, sold under the Lyons ReadyCare and Sysco Imperial brands, were distributed mainly to healthcare facilities, including nursing homes and hospitals. The outbreak, identified in 2018, has affected individuals through 2025.
As of February 21, 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 have been hospitalized, and 11 deaths have been reported. Of the 38 people, 34 (89 percent) reported living in long-term care facilities or were hospitalized prior to becoming sick. Records reviewed from facilities indicated that nutritional shakes were available to residents. The FDA is continuing its investigation in collaboration with Lyons Magnus and Prairie Farms Dairy, Inc. to identify the source of contamination and determine if further recalls are needed.
Symptoms of listeriosis, caused by Listeria monocytogenes, typically appear within two weeks of exposure, though they may develop later. Mild symptoms include fever, muscle aches, nausea, and diarrhea, while severe cases may involve confusion, stiff neck, and convulsions. Vulnerable groups, such as the elderly, pregnant women, and those with weakened immune systems, are at higher risk of severe illness.
Healthcare providers are advised to remove affected products from foodservice operations, thoroughly clean and sanitize any contaminated areas, and follow FDA guidelines to prevent cross-contamination. Listeria can survive in refrigerated environments, posing a risk to other foods and surfaces.
The FDA, CDC, and local health authorities continue to monitor the situation, with further updates to follow.
For more information, view the FDA recall here.
Compliance Perspective
Issue
The recent FDA recall of certain frozen supplemental shakes, linked to a Listeria monocytogenes outbreak, presents critical safety concerns for healthcare facilities, especially those serving vulnerable populations in long-term care settings. Facilities must remove the recalled shakes from service, properly sanitize affected areas, and follow FDA guidelines to prevent further illness or death.
Discussion Points
Ensure that the facility’s food safety policies reflect the latest FDA recall and safety recommendations. These policies should outline steps for identifying and removing recalled frozen shakes, sanitizing affected areas, and implementing appropriate cleaning procedures to avoid cross-contamination. Facilities should also establish protocols for reviewing and responding to future recalls.
Train staff on the specifics of the recall, including which shakes are affected (Lyons ReadyCare and Sysco Imperial brands) and the potential risks of Listeria infection. Staff should be educated on how to properly handle and dispose of recalled products, how to disinfect surfaces and equipment that may have come into contact with the contaminated shakes, and the symptoms of listeriosis to watch for in residents. Make sure that all staff, including food service, healthcare providers, and housekeeping and maintenance personnel understand how to mitigate risks and protect residents.
Implement regular audits of food products and equipment to ensure compliance with safety guidelines. Facilities should closely monitor the use of nutritional shakes to ensure they meet safety standards and are free from contamination. This includes confirming that recalled products are fully removed from stock and documenting the proper disposal and cleaning process. Facilities should also establish a protocol for regular checks of food suppliers and their recall status to prevent future issues.
*This news alert has been prepared by Med-Net Concepts, Inc. for informational purposes only and is not intended to provide legal advice.*
