FDA Issues Top-Level Risk Warning in Ongoing Cookie Recall

The FDA has issued a highest-risk recall for popular cookies after discovering a dangerous allergen mix-up that could pose serious health risks to individuals with food allergies.

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FDA Cookie Recall
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In a critical move, the U.S. Food and Drug Administration (FDA) has issued a Class I recall for Lunds & Byerlys Monster Cookies due to a labeling error that omitted crucial allergen information. The recall affects hundreds of cookies sold in Minnesota stores, posing a severe health risk to individuals with peanut, egg, and soy allergies. The FDA has classified the recall as high-risk, warning of the potential for life-threatening allergic reactions.

The recalled cookies, which were available for purchase between November 15 and December 9, 2025, are being withdrawn from stores in the Twin Cities and St. Cloud areas. According to the FDA, the mistake arose from an incorrect ingredient label applied to the Monster Cookies, which was originally intended for a completely different product, the Tex-Mex Turkey Wrap. This labeling issue left out the presence of peanuts, eggs, and soy, making the cookies dangerously unsafe for individuals with allergies to those ingredients.

Health Risks of Allergen Exposure

The FDA’s recall has been classified as Class I, the most severe level, reflecting the potential risk of serious health consequences. People with allergies to peanuts, eggs, or soy are at an increased risk of severe, and sometimes fatal, allergic reactions if they consume these affected cookies. These reactions can range from mild symptoms, such as itching and stomach discomfort, to anaphylaxis, a potentially life-threatening condition that can cause difficulty breathing, a drop in blood pressure, and even shock.

According to Lunds & Byerlys, the recall was prompted when a store employee identified the mislabeling, which occurred when the packaging from a separate product was mistakenly applied to the cookies. The affected product includes 108 cases of Monster Cookies, each containing 12 units, which were distributed across the stores between November and December 2025. 

The risk posed by these cookies is particularly significant because peanuts, eggs, and soy are among the most common allergens, with peanut allergies, in particular, being one of the leading causes of fatal food-related reactions in the U.S. Food allergies can trigger unpredictable and severe reactions, even from trace amounts of the allergen. This underscores the importance of accurate labeling and consumer vigilance, especially when it comes to food products sold at retail locations. 

What Affected Consumers Should Do

No illnesses have been reported in connection with the recalled cookies thus far, but customers who purchased the affected products are urged to take immediate action. According to the company’s recall notice, individuals who bought the Monster Cookies should return them to any Lunds & Byerlys store for a full refund, and no receipt is required. The company has also set up a customer service line, available daily from 9 a.m. to 9 p.m., for consumers seeking more information or assistance with returns.

The recall has raised concerns about the potential for cross-contamination in food manufacturing, particularly in large-scale production facilities. Even trace amounts of allergens can be enough to cause severe reactions, highlighting the need for strict food safety measures in packaging and labeling. Food manufacturers are urged to double-check their labels and ensure that consumers are protected from such risks, especially for products that are commonly sold in busy, high-traffic stores.

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