More than 64,000 pounds of butter have been pulled from distribution across the United States after the US Food and Drug Administration (FDA) escalated its recall classification, citing risks tied to an undeclared milk allergen.
The FDA butter recall, which originally began on 14 July as a voluntary action by food manufacturer Bunge North America Inc., was officially upgraded to a Class II recall on 30 July. That designation means the product could cause 'temporary or medically reversible adverse health consequences,' although the risk of serious outcomes is considered remote.
The product in question is the NH European Style Butter Blend. It was distributed to twelve locations across the US and one centre in the Dominican Republic. According to FDA guidelines, milk is one of the nine major allergens that must be clearly declared on all food labels.
A Common Ingredient, Critically Omitted
Though butter products are generally understood to contain milk, the FDA requires clear labelling for allergens due to the severity of potential reactions. The issue in this FDA butter recall stemmed from the NH European Style Butter Blend not listing milk on its packaging, despite being dairy-based.
The affected batches were packaged in white paperboard cases with 36 one-pound blocks per case, carrying the lot code 5064036503. These products were reportedly not sold directly to consumers, but rather distributed through food manufacturing channels, as noted in The Healthy's report.
FDA policy mandates detailed labelling, especially for known allergens. As stated on the agency's website, this is to protect individuals from potentially life-threatening reactions, such as anaphylaxis—a severe allergic response that can lead to shock or even death if untreated.
Elevated Risk Triggers Stricter Oversight
The move from a standard recall to a Class II recall underscores the seriousness of allergen labelling lapses. As explained by the FDA, the Class II status is reserved for situations where health effects are possible but not likely to be severe.
Despite the apparent low probability of serious consequences, undeclared milk poses a specific threat to individuals with dairy allergies. According to the advocacy group Food Allergy Research & Education (FARE), milk allergy is the most prevalent among children and is also common in adults. Past data cited by FARE estimates that over 6 million Americans may have a milk allergy.
As of this writing, there have been no confirmed reports of illness related to the recalled butter blend, according to USA Today. Bunge North America has not issued a public comment in response to the elevated recall level.
Labelling Regulations and Manufacturer Oversight
The core issue behind the FDA butter recall appears to be a failure to comply with allergen labelling laws, not the safety of the ingredient itself. Though milk is a standard component in butter and margarine blends, federal regulations require it to be explicitly listed to safeguard allergic individuals.
The recall's target product, the NH European Style Butter Blend, is described on Bunge's website as having a higher oil content than traditional margarines. This is aimed at enhancing flavour and texture in prepared foods.
Given the nature of its distribution, it's unlikely the recalled product was widely available on retail shelves. However, food manufacturers who rely on Bunge's ingredients may need to double-check formulations or finished goods made from the affected batches.
While no injuries have been reported, the FDA advises consumers who may have consumed the affected butter and experience any signs of an allergic reaction, such as hives, swelling, or difficulty breathing, to seek immediate medical attention.
Regulatory Implications Moving Forward
The FDA butter recall highlights how even minor oversights in labelling can carry significant public health implications. It also serves as a reminder to food producers of the critical importance of accurate allergen declarations.
Milk, along with eggs, shellfish, tree nuts, peanuts, wheat, soybeans, fish, and sesame, falls under the FDA's list of major food allergens. Federal law requires heightened disclosure for these ingredients to prevent accidental exposure and allergic reactions.
As investigations continue, regulatory authorities are likely to keep a closer watch on compliance within the food labelling sector, especially in complex supply chains where products like butter blends are sold in bulk and processed further before reaching consumers.
