The U.S. Food and Drug Administration (FDA) escalated the nationwide butter recall from Bunge North America to Class II, the second-highest warning level for this recall. Class II warnings state that the health effects, if any, are temporary or medically reversible upon consumption. This recall involves 64,800 pounds of NH European Style Butter Blend, recalled initially on July 14 for undeclared milk allergens in the product.
Recall timeline and FDA classification
On July 14, Bunge North America, Inc. initiated a voluntary recall after noting that milk, a common food allergen, was not listed on the product label. The FDA made its change in classification on July 30, defining this as Class II: “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.” So far, no adverse events have been reported with regards to this recall.
What Is a Class II recall?
FDA uses a three-tier classification system to characterize the severity of food safety recalls.
- Class I: there is a reasonable probability that use or exposure will cause serious adverse health consequences or death.
- Class II: use or exposure may cause temporary or medically reversible adverse health consequences, with remote probability of serious outcomes.
- Class III: use or exposure is not likely to cause adverse health consequences.
By ramping up the recall to Class II, the FDA puts the case on consumers with allergies or other sensitivities to milk reacting to the product with hives, swelling, vomiting, or respiratory symptoms, although serious reactions are not likely.
Scope of distribution
The butter products were distributed to twelve other distribution centers in the United States and one in the Dominican Republic. From there, these centers further shipped the products to food service providers, restaurants, and retailers across the country. Although no specific geographical breakdown of retail locations was released, the obvious network in the area makes consumer checking very worthwhile.
Among the nine major food allergens identified by FDA, milk is alongside eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. The allergic reactions due to milk protein can be from very mild symptoms of itching, hives, or upset stomach to severe anaphylaxis, which may be life-threatening without prompt medical attention. Since milk was not declared on the label, the product put consumers with known milk allergies or lactose intolerance at risk.
Consumer guidance and next steps
One action of FDA is to inform consumers who purchase NH European Style Butter Blend:
- Look for a lot code, which is 5064036503, a UPC, which is 1 00 78684 73961 2, or product code 5023937, printed on the product packaging.
- Do not eat the product if it matches the recall identifiers.
- Throw away the butter by disposing of it in a secure trash container or return it to the point of purchase for a full cash refund.
- Seek immediate medical attention if any allergic symptoms occur after consumption, and such emergency medication as epinephrine should be considered in the case where it is prescribed.
Distributors and retailers must clear all stocks of affected batches from their shelves and storage facilities and inform their respective clientele of the product recall. Though Bunge North America hasn’t received reports for any confirmed illnesses due to this recall so far, it warns consumers with milk allergies to remain alert.
Regulatory context and industry implications
This incident calls attention to the strict allergen labeling requirements set forth in the Food Allergen Labeling and Consumer Protection Act of 2004, which requires packaged foods to have major allergens clearly identified under their common name. Even products that are inherently assumed to have milk, like butter, require declaring the substance so as not to leave consumers vulnerable.
Across the industry, this recall serves as a reminder for food manufacturers to maintain strict quality control and labeling accuracy. Allergenic mislabeling erodes consumer trust, prompts regulatory action, and may expose companies to liabilities in terms of legal measures.
Consumers should immediately check their butter supplies against the specified lot and UPC codes, dispose of or return any affected product, and seek medical attention should allergic symptoms develop. Retailers must ensure that all batches affected are removed from circulation to safeguard public health.
