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.

Washington State Firm Recalls RTE Chicken Caesar Wraps Due to Undeclared Anchovies (Fish)

LPK1, a Renton, Wash. establishment, is recalling approximately 303 pounds of ready-to-eat chicken Caesar wrap products due to misbranding and an undeclared allergen - the product’s individually-wrapped Caesar dressing packet contains fish (anchovies) which is not declared on the product label.  The problem was discovered by the establishment during a routine quality assurance check of ingredient labels. The establishment then notified FSIS that the product may contain fish (anchovy), which is not declared on the label.

https://www.fsis.usda.gov/recalls-alerts/lpk1-recalls-ready-eat-chicken-caesar-wrap-products-due-misbranding-and-undeclared
LPK1 Recalls Ready-to-Eat Chicken Caesar Wrap Products Due to Misbranding and Undeclared Allergen

WASHINGTON, Feb. 23, 2025 – LPK1, a Renton, Wash. establishment, is recalling approximately 303 pounds of ready-to-eat chicken Caesar wrap products due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product’s individually-wrapped Caesar dressing packet contains fish (anchovies), a known allergen, which is not declared on the product label.

NJ Firm Recalls Dark Chocolate Novelties Due to Undeclared Milk

Kayco, a Bayonne NJ company is recalling their Glicks Dark Chocolate Conettos because it may contain undeclared milk.  This recall was initiated after the company was notified by their Quality Control Department that a limited number of bags labeled as “Dark Chocolate Conettos” contained Milk Chocolate Conettos, which contains milk allergen that is not declared on the label.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kayco-issues-allergy-alert-undeclared-milk-limited-units-glicks-dark-chocolate-conettos
Kayco Issues an Allergy Alert on Undeclared Milk in Limited Units of Glicks Dark Chocolate Conettos
Summary
Company Announcement Date:  February 21, 2025
FDA Publish Date:  February 21, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared milk allergen
Company Name:  Kayco
Brand Name:  Glicks
Product Description:  Dark Chocolate Conettos

Frozen Supplemental Shakes Linked to Listeria Outbreak Impacting Long-Term Care Residents

The FDA and CDC are linking a multistate outbreak of Listeria monocytogenes infections  Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes.  This product, used a nutrient supplement, was used in long-term care facilities which would have high-risk consumers for Listeria.  Cases date back to 2018.  There have been 38 reported cases with 11 deaths.

"On November 25, 2024, FDA was notified about an outbreak of Listeria monocytogenes in the United States, with many ill people residing in long-term care facilities (LTCF) prior to illness onset. FDA’s traceback investigation identified that each of the LTCF who supplied invoice information for review from 2024 to present received a frozen supplemental shake of either Lyons ReadyCare or Sysco Imperial brand. As part of this investigation, FDA collected environmental samples and found the outbreak strain of Listeria."

"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. 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."

Lyons Magnus LLC (“Lyons Magnus”), Fresno CA, announced that it is voluntarily recalling 4 oz. Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes due to the potential for the products to be contaminated with Listeria monocytogenes. 

Case Counts
Total Illnesses: 38
Hospitalizations: 37
Deaths: 11
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

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-listeria-monocytogenes-frozen-supplemental-shakes-february-2025
Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes (February 2025)
Content current as of: 02/21/2025
Do not sell or serve Lyons ReadyCare and Sysco Imperial Frozen Supplemental Shakes. FDA’s investigation is ongoing.

Importer Recalls Snack Products After Foreign Supplier Fails on Allergen Labeling

ZB Importing LLC. Cicero, IL, is voluntarily recalling certain lots of six varieties of Ulker Brand snack rolls, biscuits, and wafers due to undeclared wheat, egg and/or milk in the Ingredient List and/or Contains Statement on the product labels.  This mislabeling was discovered following receipt of a single consumer complaint involving an allergic reaction. The issue originated from a supplier who inadvertently failed to fully disclose all allergens while translating the ingredient list. [The company is] actively working with the supplier to implement stricter labeling controls, including an additional verification process for multilingual labels.

Ulker branded product is imported from Turkey.

The importer in this case, ZB Importing LLC., is responsible for assuring proper allergen labeling through their foreign supplier verification program (FSVP).   Allergens would have been identified on the hazard analysis for  product from that company, and the importer would need measures to ensure that proper allergen control was implemented, specifically in this case, label declaration of allergens.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/zb-importing-issue-voluntary-recall-and-allergy-alert-undeclared-egg-wheat-and-milk-certain-ulker
ZB Importing Issue Voluntary Recall and Allergy Alert on Undeclared Egg, Wheat and Milk in Certain Ulker Brand Products
Summary
Company Announcement Date:  February 18, 2025
FDA Publish Date:  February 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (wheat, eggs, milk)
Company Name:  ZB Importing LLC
Brand Name:  Ulker
Product Description:  Snack rolls, biscuits, and wafers

Texas Firm Recalls Snack Mix For Missing Allergen Labeling

KEDAKE, INC. of Houston, TX is recalling it’s 2 lb packages of Las Ollas Botana Mix Snacks because they may contain undeclared Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6.  Las Ollas Botana Mix Snacks 2 lb packages were distributed in Texas and reached consumers through both wholesale and retail stores.   The recall was initiated after the FDA discovered in a routine inspection that the product containing the Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6 was distributed in packaging that did not reveal the presence of these ingredients and subsequent investigation indicated that the problem was caused by a production printing problem with the label.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/kedake-inc-issues-allergy-alert-undeclared-sesame-soy-wheat-yellow-no-5-yellow-no-6-and-red-no-6
Kedake Inc. Issues Allergy Alert on Undeclared Sesame, Soy, Wheat, Yellow No. 5, Yellow No. 6, and Red No. 6 in Botana Mix Snacks
Summary
Company Announcement Date:  February 20, 2025
FDA Publish Date:  February 20, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared wheat, sesame, soy, yellow 5, yellow 6, red 6
Company Name:  Kedake Inc
Brand Name:  Las Ollas
Product Description:  Las Ollas Botana Mix Snacks and Delights 2 lb packages

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Georgia Firm Recalls Snack Pack Product for Undeclared Allergens After Incorrect Back Label Applied

Naturipe Value Added Fresh LLC. of Alma, GA, is recalling its 2.1 oz./60 gram packages of "Berry Buddies, Berries & Pancakes" bento box snack packs because they contain wheat and EGGS that were not declared on the label.  The recall was initiated after it was discovered that the incorrect back label was placed on the back of the package. Because of this, the allergens of WHEAT and EGGS were not listed on the label. Subsequent investigation indicates the problem was caused by a production label changeover failure which has since been corrected.


https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/naturipe-value-added-fresh-llc-issues-allergy-alert-undeclared-wheat-eggs-berry-buddies-berries
Naturipe Value Added Fresh LLC Issues Allergy Alert On Undeclared Wheat & Eggs In "Berry Buddies, Berries & Pancakes” Lot # 1097901
Summary
Company Announcement Date:  February 18, 2025
FDA Publish Date:  February 19, 2025
Product Type:  Food & Beverages
Reason for Announcement:  Undeclared allergen (wheat, eggs)
Company Name:  Naturipe Value Added Fresh LLC
Brand Name:  Naturipe Snacks
Product Description:  Berry Buddies, Berries & Pancakes bento box snack packs

Milk Chocolate Covered Macadamias Recalled for Undeclared Almonds

Mauna Loa Macadamia Nut Company LLC of Kea’au, HI is voluntarily recalling one batch of its Mauna Loa Milk Chocolate Covered Macadamias snack (1oz) pouches, due to the presence of undeclared almonds which are an allergen.  The recall was initiated after Mauna Loa’s internal quality control process identified that the affected batch, manufactured by a third-party co-manufacturer, contained undeclared almonds. Immediate action was taken to contain the affected product, notify the third-party co-manufacturer, alert consumers and distributors, and report the issue to the FDA.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mauna-loa-macadamia-nut-company-llc-issues-product-recall-undeclared-almonds-mauna-loa-milk
Mauna Loa Macadamia Nut Company, LLC Issues a Product Recall on Undeclared Almonds in Mauna Loa Milk Chocolate Covered Macadamias (1oz) Pouches
Summary
Company Announcement Date: February 15, 2025

FDA Publish  Date: February 15, 2025

Product Type: Food & Beverages

Reason for Announcement:  Undeclared almonds

Company Name: Mauna Loa Macadamia Nut Company, LLC

Brand Name: Mauna Loa

Product Description: Mauna Loa Milk Chocolate Covered Macadamias