A recall of an ice cream product has been issued the second-highest risk warning by the U.S. Food and Drug Administration (FDA) just days before Thanksgiving.

Jeni’s Splendid Ice Creams LLC, based in Ohio, issued a voluntary recall for a select amount of its Jeni’s Passion Fruit Dreamsicle Ice Cream Bars on November 17 due to undeclared allergens (wheat and soy). The FDA later issued a Class II risk classification for the recall on November 24.

Why It Matters

Wheat and soy are two of the nine major food allergens as defined in law. The others are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, and sesame.

The FDA warned in its initial recall notice: “People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reactions if they consume these products.”

Allergic reactions vary in severity from mild symptoms, such as hives and lip swelling, to life-threatening complications, such as anaphylaxis, which may include fatal respiratory problems.

A Class II risk classification, one of three, refers to a situation in which the “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the FDA.

What To Know

The product affected by the recall is the following:

Jeni’s Passion Fruit Dreamsicle Ice Cream Bars—3,767 cases—best-by date: October 2026—Lot number: 25-210—UPC codes: 850060644122, 10850060644129

The product was distributed to grocery stores nationwide, the FDA said.

The recall was initiated a crunch topping from another product was introduced into this batch of ice cream bars by accident during the manufacturing process, the agency said.

The crunch topping contained wheat and soy, which were not declared on the recalled product’s labels.

As of November 17, no illnesses had been reported in connection with the consumption of the recalled ice creams.

What People Are Saying

A spokesperson for Jeni’s Splendid Ice Creams LLC told Newsweek: “We have initiated a voluntary recall of Lot #25-210 of the Passion Fruit Dreamsicle Ice Cream Bar 3pk carton and 8pk cases because of the potential presence of undeclared allergens (wheat and soy). People who have an allergy or severe sensitivity to soy and wheat run the risk of serious or life-threatening allergic reactions if they consume these products. 

“No illnesses or reactions have been reported to date. However, out of an abundance of caution, we have made the decision to recall the product. No other Jeni’s products or flavors are affected.”

The FDA says on its website: “People with food allergies should read labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food.”

Dr. Sebastian Lighvani, the director of New York Allergy & Asthma, previously told Newsweek: “Every three minutes in the United States, someone ends up in an emergency room because of an allergic reaction after accidental ingestion of food. So even when we try hard, these reactions are happening. And if you look at the incidence of anaphylaxis, it has skyrocketed in the last five, 10, 20 years. And in the U.S., there’s like a 300 to 400 percent increase in the rates of anaphylaxis to foods.”

What Happens Next

The recall is listed as ongoing, according to the FDA.

Customers who purchased the recalled product should not consume it and are urged to return it to the place of purchase for a full refund.

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