mobile-logo

On February 21, 2025, Lyons Magnus initiated a voluntary nationwide recall of its Ready Care and Sysco Imperial frozen nutritional shakes after the discovery of Listeria monocytogenes, a potentially deadly foodborne pathogen. This contamination resulted in 38 hospitalizations and 12 fatalities across 21 U.S. states. [1]

FDA Recall Notice: Ready Care & Sysco Imperial Shakes by Lyons Magnus Due to Listeria Contamination

Recall , July 14, 2025

Share
Mail-bulk Linkedin X-twitter

On February 21, 2025, Lyons Magnus initiated a voluntary nationwide recall of its Ready Care and Sysco Imperial frozen nutritional shakes after the discovery of Listeria monocytogenes, a potentially deadly foodborne pathogen. This contamination resulted in 38 hospitalizations and 12 fatalities across 21 U.S. states. [1]

Root Cause Analysis

  • Poor hygiene in production areas: Contaminated surfaces, especially in cold-chain zones.
  • Missed validation of kill-step for Listeria: Lack of microbial lethality verification during pasteurization or sterilization.
  • Lack of HACCP implementation and audit: Missing hazard analysis and control measures, with no proper documentation.
  • No environmental swabbing or sanitation monitoring: No routine pathogen monitoring in equipment or air vents. [2]

Table: 1

 

Lapses Identified

Explanation

·        Poor hygiene in production environment

·       Contaminated surfaces in cold-chain zones

·        Missed kill-step validation for Listeria

·       No microbial lethality verification during pasteurization or sterilization

·        Lack of HACCP implementation and audit

·       Hazard analysis and control steps were either not followed or documented

·        No environmental swabbing or sanitation monitoring

·       No routine pathogen monitoring across equipment or air vents

Product Description

Brand Name: Lyons Magnus

Product Names:

  • Ready Care Frozen Nutritional Shake
  • Sysco Imperial Frozen Nutritional Shake

Category: Frozen medical nutrition / clinical dietary supplement

Form: Ready-to-serve frozen bottles

Intended Use: For those who need clinical or elderly care nutrition, such as patients with dietary limitations

Issue: Listeria monocytogenes – a serious foodborne pathogen

Distribution: Nationwide, through hospitals, care facilities, medical wholesalers, and foodservice channels

 

FDA Recall Lyons Magnus Ready Care & Sysco Imperial Shakes (Listeria Risk) blog

Affected Lots: Complete list of batches to be published by Lyons Magnus and FDA; representative samples include:

Lot RC1124 – Best By: May 2025

Lot SI2402 – Best By: June 2025

Lot RC2201 – Best By: April 2025

Lot SI2410 – Best By: July 2025 [3]

Issue Identified

Frozen shakes contained Listeria monocytogenes, a bacterium with serious health consequences specifically for pregnant women, older adults, immunocompromised, and those with medical conditions.

Reported symptoms:

  • Extreme high fever
  • Muscle pain
  • Gastrointestinal upset
  • Confusion or neurological symptoms in severe cases

The outbreak caused 12 deaths and 38 hospitalizations, which resulted in urgent recall of the affected products.  [4]

Regulatory Body Issues

  • The FDA and CDC cooperatively launched an investigation into the outbreak and product traceback
  • The plant was deemed noncompliant with Good Manufacturing Practices (GMP)
  • Lyons Magnus was instructed to cease operations until sanitation improvements and protocol adjustments [1]

The recall was graded as a Class I Recall highest level of severity because of life-threatening risk

Table: 2

Agency

Action Taken

FDA

Facility inspection, production halt, oversight of corrective actions

CDC

Case monitoring, outbreak mapping, coordination with public health departments

Lyons Magnus

Product withdrawal, consumer alerts, sanitation protocol overhauls

Consumer Guidance by Manufacturer

Lyons Magnus has advised all parties, including consumers, to:

  • Discontinue use of Ready Care and Sysco Imperial frozen nutritional shakes immediately from impacted lots
  • Dispose of the product safely or return it to the place of purchase
  • Health institutions should quarantine and dispose of stock from affected batches
  • Anyone who develops symptoms after use should receive medical attention immediately
  • Report adverse events to FDA MedWatch
  • Lyons Magnus is adopting new microbial surveillance procedures and strengthened sanitation controls [5]

FRL Commentary

This recall serves as a harsh reminder that prevention of pathogens in clinical nutrition items needs to be more than standard food safety practices.

FRL advises manufacturers of medical foods and supplements:

  • Conduct validated environmental swab testing in refrigerated areas
  • Implement predictive microbiology model for Listeria and other pathogen
  • Perform third-party GMP audits on a quarterly basis
  • Implement lot-level traceability and create cold-chain risk assessments

Priority Action

Description

·        Environmental Swabbing Program

·       Routinely test production zones and air ducts for Listeria

·       HACCP with Pathogen Kill-Step Validation

·       Validate thermal or sterilization procedures

·        Cold-Chain Risk Analysis

·       Ensure temperature integrity and microbial risk modeling

·       GMP Training & Third-Party Audits

·       Train staff, enforce SOPs, and audit facilities quarterly

Meticulous food safety engineering and sustained compliance monitoring are what protect the health of at-risk populations.

Finalizing Comments

The Ready Care and Sysco Imperial shake recall is a high-impact illustration of how hygienic failure and microbial control breakdown can result in disastrous public health repercussions. Microbial safety must be treated by clinical nutrition manufacturers as a mission-critical concern particularly for cold-chain and high-risk food segments.

Don’t wait for a recall to test your safety system!  Partner with FRL today to ensure your operations are recall-resistant, regulation-aligned, and consumer-trusted.

Food Research Circle Logo
Let’s create something Innovative and Delicious together

Food Research Lab strives for excellence in new Food, Beverage and Nutraceutical Product Research and Development by offering cutting edge scientific analysis and expertise.

New Product Concepts

New Product Concepts
Sample Request

Sample Request
Quote Request

Quote Request
Connect An Expert

Connect an Expert
whatsapp