FDA Issues Nationwide Recall of 64,800 Pounds of Butter Over Undeclared Milk Allergen

On July 14, 2025, Bunge North America Inc. voluntarily initiated a recall of 1,800 cases (a total of 64,800 pounds) of its NH European Style Butter Blend. The U.S. Food and Drug Administration later classified this recall as Class II, signaling a serious health concern: the product contained milk allergens that were not declared on the label, posing life‑threatening risks for those with milk allergies

🧈 Product Details: What Was Recalled?

The affected product is NH European Style Butter Blend, produced by Bunge North America of Chesterfield, Missouri. It’s distributed in white paperboard cases, each containing 36 one-pound blocks. The recall applies to cases bearing:

UPC code: 1 00 78684 73961 2
Lot code: 5064036503

Distribution reached 12 centers across the United States, as well as one center in the Dominican Republic The product appears to be intended primarily for food-service or industrial use, rather than direct retail sale, though consumers may still encounter it via bulk channels

⚠️ Why This Recall Matters

The presence of undeclared milk is a major violation of FDA labeling laws. Milk is one of the “Big Nine” major food allergens, and failure to disclose it may trigger severe allergic reactions—including anaphylaxis—in vulnerable individuals. While no illnesses have been confirmed so far, the FDA elevated the recall to Class II, its second-highest risk classification, on July 30, 2025 due to the potential for medically reversible adverse health effects

Symptoms of a mild allergic reaction may include hives, vomiting, facial swelling, or gastrointestinal upset. For severe cases, exposure can lead to full-blown anaphylaxis, requiring immediate medical attention

✅ What Consumers Should Do

If you believe you may have this butter in your possession:

Check the packaging carefully for UPC 1 00 78684 73961 2 and lot 5064036503.
Do not consume the product if it matches the description.
Discard it safely in sealed bags or return it to the place of purchase for a refund.
If you’ve already consumed it and experience allergy symptoms, stop eating immediately, consider using emergency medication (like epinephrine if prescribed), and seek medical attention

Bunge North America and retailers are expected to cooperate with returns and refunds, particularly given the voluntary nature of the recall.

📌 Background: Why the Recall Was Escalated

Initially issued as a lower-risk recall, the FDA raised the classification to Class II after further review. FDA guidance defines Class II as situations where temporary or medically reversible health consequences are possible, but serious harm is unlikely

This escalation underscores how critical accurate allergen labeling is—especially given that milk allergy is common, particularly in children. The risk may be remote for the general population, but heightened for those with known allergies

🌍 What Else You Should Know

The recall is nationwide, covering multiple states and extending into international distribution (Dominican Republic)
No health incidents have been reported in connection with the butter recall so far
Although the product seems to serve commercial or industrial sectors, it raises broader concerns about food production oversight and quality controls within large ingredient suppliers like Bunge
Bunge has reportedly initiated an internal review to prevent future lapses in labeling accuracy and product safety

By..Wilgens Sirise

FDA Issues Nationwide Recall of 64,800 Pounds of Butter Over Undeclared Milk Allergen