The U.S. Food and Drug Administration (FDA) has elevated the recall classification for 64,800 pounds of Bunge North America Inc.’s European Style Butter Blend to a Class II level, signaling a higher risk of potential health consequences. The recall, originally issued voluntarily by the company on July 14, involves 1,800 cases of the butter product, which contained undeclared milk not listed on the packaging label.
A Class II recall indicates a situation where use or exposure to a violative product may lead to temporary or medically reversible adverse health effects, with a remote probability of serious outcomes. The FDA officially raised the classification on July 30, following an internal review of the product’s allergen risk. Milk is recognized as one of the nine major food allergens that require clear labeling under FDA regulations to prevent allergen-related health incidents.
Bunge North America, headquartered in Chesterfield, Missouri, reported that the recalled butter was packed in white paperboard cases, with each case containing 36 one-pound blocks. These products were distributed to 12 centers across the United States and an additional center in the Dominican Republic. The affected butter carries the lot code 5064036503 and UPC code 1 00 78684 73961 2.
FDA raises Bunge butter recall to Class II after allergen risk assessment
The product was also available through online retailers and food service suppliers, increasing the scope of potential exposure. The FDA emphasized that individuals who consume the affected product and experience symptoms of an allergic reaction such as hives, facial swelling, nausea, difficulty breathing, or dizziness should cease consumption immediately.
In severe cases, exposure to undeclared milk allergens can trigger anaphylaxis, a life-threatening reaction that requires urgent medical intervention, including the administration of epinephrine. Despite the recall escalation, the FDA has not confirmed any reported illnesses linked to the consumption of the recalled butter as of August 2.
Bunge North America has not provided public comment regarding the incident or the FDA’s updated risk classification. Consumers are advised to inspect their butter products carefully, verifying the product name, packaging, lot code, and UPC against the recall details. The FDA’s enforcement report recommends that affected products should not be consumed, donated, or redistributed.
FDA advises immediate action if allergy symptoms appear post-consumption
Consumers may return the recalled butter to the point of purchase or contact Bunge North America directly for further instructions through the company’s official website. The agency continues to monitor the situation and enforce compliance with allergen labeling requirements to ensure consumer safety.
This incident underscores the FDA’s ongoing efforts to enforce strict allergen disclosure regulations, particularly for packaged food products. Alongside milk, other major allergens requiring declaration include eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Failure to comply with these regulations can result in product recalls, enforcement actions, and potential health risks for allergic consumers.
Bunge North America is a major supplier of agricultural commodities and food ingredients, including oils, grains, and protein sources. The company’s portfolio spans multiple sectors within the food manufacturing and distribution industries. The recall is part of a broader regulatory initiative aimed at minimizing risks associated with undeclared allergens in the food supply chain. – By Content Syndication Services.