The FDA Is Giving Undeclared Milk in Products Its Most Severe Recall Classification: Here’s Why

Food recalls are unfortunately not a new thing, but there’s been a definite trend lately around a specific allergen. The Food and Drug Administration’s (FDA) recall list currently features several products being yanked from shelves due to “undeclared milk”—and it includes some big name brands. 

Two of these recent recalls were originally listed as lower levels of risk, only to later be upgraded to the FDA’s most severe risk classification. One is a recall issued in mid-December of Lay’s 13-ounce bags of Classic Chips due to “undeclared milk.” But in late January, the FDA upgraded the recall to Class I, which is the agency’s most severe classification. A Class I designation means that “the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

The FDA also upgraded a mid-December recall of Cal Yee Farms' dark chocolate almonds, dark chocolate apricots, and dark chocolate walnuts to a Class I designation due to undeclared milk. Two more products—Fresh Direct’s dark chocolate covered pretzels and Shirakiku’s Curvee Puffs corn puff snacks—were also just yanked from shelves due to an undeclared milk allergen. 

The recalls are raising a lot of questions about the severity of milk allergens, plus why it’s so bad when milk isn’t listed on a label. Here’s what an allergist and food safety experts want you to know. 

Why is undeclared milk in a product so serious?

Milk allergies impact an estimated 2 to 3 percent of children under age 3, although the allergy is considered rare in adults. Like all allergies, milk allergies can be serious. 

“If someone has a milk allergy and is exposed, it can trigger an allergic reaction which can be severe or life threatening,” says Purvi Parikh, M.D., an allergist with Allergy & Asthma Network. 

Reactions vary by person, but may include hives, upset stomach, vomiting, bloody poop, and anaphylaxis, a rare and potentially deadly allergic reaction that interferes with breathing, according to the American College of Allergy, Asthma & Immunology. 

Why did these recalls escalate?

While the FDA didn’t specify why these recalls escalated, food safety experts have a few thoughts. “A company may first voluntarily recall a product during an initial investigation due to a potential allergen labeling issue—sometimes at a lower recall level, Class II or Class III, if there is uncertainty about the risk,” says Darin Detwiler, author of the book Food Safety: Past, Present, and Predictions and a professor at Northeastern University. 

But if further tests find actual milk contamination or if a person has an allergic reaction to a product, the recall may be elevated to Class I, Detwiler explains. 

Still, an undeclared allergen from one of the big nine food allergens identified in the Food Allergen Labeling and Consumer Protection Act of 2004 would typically trigger a Class I recall, says Janet Buffer, M.P.H., senior institute manager for the Institute for Food Safety and Nutrition Security at George Washington University. “Notably, both the Lay’s potato chip and Cal-Yee chocolate recalls were initiated due to the presence of milk, which is one of these major food allergens,” she says. 

As for why the allergens were not declared in the first place, Detwiler says it may be due to a recipe change or printing errors on packaging. 

Why is an allergen label is necessary?

Allergy labels are simple and say, “Contains: Milk” or a similar allergen to make it easy for customers to see if a product is a potential issue for them. These labels are “very necessary, as [allergies] can be life threatening,” Parikh says. 

“Allergen labeling is crucial for public safety,” Buffer says. “Accurate ingredient labeling allows individuals with food sensitivities to read labels, determine if a product is safe for them, and consume it without worry.”

Detwiler agrees. “Without clear labeling, people cannot make safe food choices,” he says.