FDA warns Lyons Magnus after ‘serious violations’ following Oatly, Glucerna recall

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Lyons Magnus recall FDA warning overview:

• Who: The FDA has issued a warning letter to Lyons Magnus.
• Why: The FDA says its inspection of a Lyons Magnus processing facility shows it was in violation of food safety regulations, after a major 2022 recall of its products.
• Where: The processing facility is in Beloit, Wisconsin.

The U.S. Food & Drug Administration (FDA) has issued a warning to Lyons Magnus after a major 2022 recall of its products from brands Glucerna, Stumptown, Intelligentsia, Aloha, Kate Farms and Premier Protein led to findings that one of the company’s processing facilities was in violation of food safety regulations.

In July 2022, Lyons Magnus LLC recalled 53 nutritional and beverage products because of potential microbial contamination, including from the organism Cronobacter sakazakii. In August, it expanded the recall by more than 100 additional products. 

In a Jan. 30 warning letter, the FDA refers to an inspection of Lyons Magnus’ aseptic processing facility in Beloit, Wisconsin, held from Aug. 3 through Sept. 14, 2022.

The inspection was initiated in response to the firm’s July 2022 recall and a lack of commercial sterility in their finished products, the FDA said. 

FDA finds positive lab results were not promptly reported 

The FDA’s inspection revealed that the firm was not in compliance with the Emergency Permit Control regulation and the Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers regulation.

According to the FDA, some of the significant violations include not promptly reporting contamination to the FDA. The FDA said when any lot of food which may be injurious to health by reason of contamination with microorganisms has in whole or in part entered distribution, it must be informed. 

While the firm reported a voluntary recall to the FDA on July 26, 2022, an FDA review of its micro testing records revealed gram-positive, gram-negative rods and cocci in approximately 37 batches of finished products that were released and shipped but were not reported to the FDA. 

“The FDA reminded the firm that their aseptically packaged products containing viable microorganisms do not meet the definition of commercial sterility, and are, therefore, adulterated,” the FDA said in the warning. 

“Shipping adulterated products into interstate commerce is prohibited. The firm must promptly alert the FDA of lots shipped with known microbial contamination, not just those lots with confirmed species as identified in July 2022.” 

Additionally, the company shipped the products without conducting a full investigation into the cause of the microbial contamination, the FDA said. 

The FDA also said commercial sterility was not promptly ensured in the facility. Although Lyons Magnus was aware of the April 2022 microbiological contamination, the firm did not stop processing until July 15, 2022, and began an internal investigation on July 16, 2022, it said. 

In November, Lyons Magnus was hit with a class action lawsuit alleging it failed to ensure the quality of its products. 

What do you think of the FDA’s findings? Let us know in the comments.

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