The U.S. Food and Drug Administration (FDA) announced the recall of frozen supplemental shakes distributed to hospitals, long-term care facilities, and other institutions.
The frozen shakes are linked to a listeria outbreak that has caused 37 hospitalizations and 11 deaths.
"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," the FDA announced.
"According to CDC, this outbreak includes cases dating back to 2018, with 20 cases across 2024 and 2025, and is currently ongoing. Epidemiologic evidence in previous investigations were unable to identify a source of the outbreak. As of February 21, 2025, a total of 38 people infected with the outbreak strain of Listeria monocytogenes have been reported from 21 states," the announcement continued.
"Of the 38 people for whom information is available, 37 people have been hospitalized. Eleven deaths have been reported. Of the 38 people for whom information is available, 34 (89%) reported living in long term care facilities or were hospitalized prior to becoming sick. Records reviewed from facilities indicated nutritional shakes were available to residents," it added.
The FDA announced its investigation into the outbreak Friday, saying it is working with the CDC and local agencies to track the multistate rash of illnesses, many of which occurred in patients of hospitals and nursing homes. The manufacturer also issued a voluntary recall notice for the impacted products - frozen supplemental meal shakes sold under the brand names Lyons ReadyCare and Sysco Imperial.
The recall covers all Lyons ReadyCare and Sysco Imperial frozen supplemental shakes within shelf-life.
As of Feb. 21, the FDA was aware of 38 illnesses linked to the outbreak across 21 states. Of the 38, all but one were hospitalized and 11 died. Nearly 90% of sick people reported living in long-term care facilities or were hospitalized before becoming sick.
The CDC had previously begun tracking the same outbreak in 2018, with 20 cases cropping up throughout 2024 and 2025. During the prior investigations, epidemiologists were unable to identify the source of the illnesses. Current case numbers include those that occurred between the initial 2018 incident and now, as the outbreak is ongoing.