The U.S. Food and Drug Administration (FDA) has escalated its warning regarding the recall of a popular butter blend, totaling nearly 65,000 pounds, after it was discovered to have been distributed without properly declaring milk as an allergen on its label. This isn’t just a simple mix-up; it’s a labeling oversight that presents a potentially life-threatening risk to anyone with a milk allergy.
The product at the center of this issue is the NH European Style Butter Blend, manufactured and distributed by Bunge North America, a prominent name in the food industry. Initially, the company issued a voluntary recall, but the FDA has since elevated it to a Class II recall. This classification signifies a health hazard that could lead to temporary or medically reversible adverse health effects for some consumers.
The seriousness of this situation lies in the danger posed by undeclared allergens, particularly one as common and potentially dangerous as milk. The FDA’s guidelines, established under the Food Allergen Labeling and Consumer Protection Act (FALCPA), mandate that milk—one of the nine major food allergens—be clearly listed on product labels. A failure to do so puts individuals at risk of severe allergic reactions, which can even necessitate hospitalization.
Why This Recall Is So Important
While the average shopper might dismiss this as a minor packaging error, for the millions of Americans living with milk allergies, it’s anything but. According to Food Allergy Research & Education (FARE), an estimated 6.1 million Americans are impacted by milk allergies. For these individuals, consuming an undeclared milk product can trigger anaphylaxis, a sudden and potentially fatal allergic reaction. Symptoms can range from hives and swelling to difficulty breathing and vomiting. For parents of children with known milk allergies, such a labeling failure is truly frightening.
Although no allergic reactions have been reported in connection with this recall so far, the risk remains a serious concern. The FDA’s recall notice serves as a crucial, proactive measure to alert distributors, retailers, and consumers not just across the United States, but also in the Dominican Republic, where some of the product was also distributed.
Details You Need to Know
If you’re worried you might have purchased this product, here’s what to look for:
- Product name: NH European Style Butter Blend
- Packaging: 36 x 1-pound packages per case
- Total recalled: 1,800 cases or 64,800 pounds
- UPC code: 1 00 78684 73961 2
- Lot code: 5064036503
- Distribution: 12 U.S. states and the Dominican Republic
Customers are strongly advised to check the UPC and lot codes on their product. If there is a match, you should stop using the product immediately. It should either be safely discarded or returned to the store where it was purchased for a full refund.
Understanding Class II Recalls
The FDA classifies recalls based on the potential severity of the health risk. A Class II recall, as designated here, indicates a situation where a product may cause temporary or reversible health effects, or where the probability of serious harm is low. While it’s not the most urgent category (Class I), it still represents a significant public health issue.
In this specific case, the presence of undeclared milk in the butter blend could cause a person with a milk allergy to unknowingly consume it. Even trace amounts of milk can be dangerous for allergic individuals, particularly if they are not prepared with an EpiPen or other emergency medication.
How Errors Like This Occur
Labeling errors like this can happen at various stages of the manufacturing or packaging process. A misprint, the use of outdated packaging, or a breakdown in a company’s allergen control protocols can all lead to critical omissions that go unnoticed until it’s too late.
Large food corporations like Bunge North America typically have rigorous food safety standards in place. However, this case serves as a powerful reminder that even with advanced systems, errors can still occur. This is precisely why regulatory oversight from agencies like the FDA is so vital.
The misbranding of food products, especially those involving allergens, is a violation of federal food safety laws. Beyond FDA warnings and consumer alerts, companies that repeatedly fail to comply can face significant consequences, including fines, legal action, or mandatory changes to their quality control processes.
The Bigger Picture: Food Allergy Transparency
This recall highlights the ongoing challenge of allergen transparency within the U.S. food industry. The FDA has increased its scrutiny of food manufacturers in recent years, largely due to a rise in recalls related to undeclared allergens.
In fact, undeclared allergens are the single most common reason for food recalls in the United States. Milk consistently tops this list, followed by other common allergens like wheat, soy, and eggs. The law is unambiguous: these allergens must be clearly listed either in the ingredients list or in a prominent “Contains:” statement on the label. Violations of this law put millions of lives at risk.
For people with severe food allergies, every grocery shopping trip involves a level of risk. The responsibility often falls to the consumer to meticulously check ingredients, place trust in specific brands, or seek out products specifically labeled as “allergy-friendly.”
If You Have the Recalled Product
If you or a family member has a known milk allergy, this recall is an urgent matter. Here are the steps you should take:
- Carefully check the packaging for the UPC and lot code.
- If the product matches the recalled batch, do not consume it.
- Contact the retailer to return the product for a refund.
- If you or someone in your family has consumed the butter and experiences symptoms, seek medical attention immediately.
- To stay informed about future risks, it may be beneficial to sign up for recall alerts from the FDA or FARE.
Bunge North America’s Response
In the wake of a recall, Bunge is expected to be cooperating fully with the FDA to investigate how the allergen omission occurred. The company may need to revise its labeling procedures, enhance its internal review processes, and retrain its quality control teams.
In situations like this, a company’s transparency and speed in responding can have a major impact on public trust. While a recall is never positive news, a swift and responsible response is often appreciated by consumers, especially when their safety is at stake.