FDA Issues Nationwide Class II Recall on 32 Tons of Butter

The U.S. Food and Drug Administration (FDA) has elevated a nationwide recall covering 64,800 lbs (that’s 1,800 cases) of Bunge North America’s NH European Style Butter Blend after tests showed the product’s label failed to list milk, a major allergen. The company first voluntarily pulled the butter on July 14, but the alert was upgraded on July 30, underscoring the potential risk to allergy-prone consumers.

Why Class II Matters

The FDA classifies recalls on a three-tier scale. Class II is the second most severe classification. According to the FDA website, Class II recalls are triggered when “a situation in which 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.”

Previously, the product was under a Class III recall, meaning “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.” Though life-threatening outcomes are unlikely for anyone with milk allergies, it could still be serious.

How To Spot The Recalled Butter

Be on the lookout for one-pound blocks packed 36 to a case, shipped in plain white paperboard cartons. The butter was sent out to 12 distribution centers located throughout the U.S. and one center in the Dominican Republic. Each block belongs to Lot 5064036503, UPC 1 00 78684 73961 2, Product Code 5023937. If any of those numbers match what’s in your fridge, pull it immediately.

Undeclared Milk

Milk ranks as one of the FDA’s nine major food allergies. The FDA states that “the law requires that food labels identify the food source of all major food allergens used to make the food. This requirement is met if the common or usual name of an ingredient already identifies that allergen’s food source name (for example, buttermilk).”

These “labeling requirements extend to retail and food-service establishments that package, label, and offer products for human consumption.” This is part of the FDA’s larger mission “to protect those with food allergies and other food hypersensitivities”.

According to the Mayo Clinic, milk allergy “usually occurs soon after you or your child consumes milk.” Allergic reactions vary, but the clinic says common “signs and symptoms of milk allergy range from mild to severe and can include wheezing, vomiting, hives and digestive problems. Milk allergy can also cause anaphylaxis — a severe, life-threatening reaction.”