
FDA recalls butter across US: What Class II warning means, which product has been recalled
The risk classification was raised by the FDA on Wednesday, July 30.
Why was butter recall issued and who is to blame?
The butter recall for 64,800 lbs (or 1,800 cases) was issued by Bunge North America Inc, which is based out of Chesterfield, Missouri.
The product that has been recalled is its European Style Butter Blend 1 lb. The voluntary recall came on July 14, and has now been escalated by the government entity.
The company said it was recalling the product because milk was undeclared and not listed on the product label. The lot code number for the butter is 5064036503.
Milk is one of the nine food allergens as per the FDA site. Food-related allergies can vary in symptoms ranging from face and lip swelling to vomiting. However, there is also the risk of severe reactions like anaphylaxis, where the immune system could release a 'flood of chemicals' which could make a person go into shock and end up being fatal for them, Mayo Clinic said.
As per the FDA, they enforce regulations to avoid such situations and they said there are 'more specific labeling requirements' for foods that can cause allergies and other hypersensitive reactions.
What does FDA's Cass II warning mean?
As per the FDA site, a Class II recall indicates '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'.
They advised people, that if anyone has consumed the product and starts to feel something is not right, they should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention.'

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Economic Times
an hour ago
- Economic Times
Over 29,000 kg of butter recalled in US for skipping one key word: Milk
Synopsis Bunge North America Inc. has voluntarily recalled over 29,000 kilos of NH European Style Butter Blend in the US due to a labelling error. The packaging failed to declare milk as an ingredient, a major allergen. Agencies Butter recall in US More than 29,000 kilos of butter have been recalled in the United States after a labelling error failed to mention milk, a major allergen, on the product packaging. The voluntary recall was issued by Bunge North America Inc. and later classified by the US Food and Drug Administration (FDA) as a Class II recall on July butter, distributed in 500-gram blocks under the NH European Style Butter Blend label, was packed in 1,800 cases. Each case contained 36 butter blocks and was shipped to 12 distribution centres across the US and one in the Dominican Republic. The company initiated the recall on July 14. Though butter is made from cream, which is derived from milk, the ingredient was not clearly mentioned on the label. Milk is considered a major allergen and must be declared under FDA FDA defines a Class II recall as '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, there are no reports of any allergic reactions linked to the recalled butter. However, the omission is considered serious due to the risk it poses to people with milk allergies. The FDA has advised that if someone with a milk allergy has consumed the butter and experiences symptoms, they should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention.' Food allergies can cause reactions ranging from mild discomfort, such as hives or swelling, to severe, life-threatening conditions like anaphylaxis. This occurs when the immune system reacts aggressively and can lead to shock if not treated prevent such risks, the FDA mandates that food packaging must clearly state the presence of any of the eight major allergens, including recall follows another incident earlier in the week involving High Noon Hard Seltzers. A labelling error led to some vodka-containing cans being incorrectly packaged as non-alcoholic Celsius Astro Vibe Energy Drinks.


Time of India
an hour ago
- Time of India
Over 29,000 kg of butter recalled in US for skipping one key word: Milk
More than 29,000 kilos of butter have been recalled in the United States after a labelling error failed to mention milk, a major allergen, on the product packaging. The voluntary recall was issued by Bunge North America Inc. and later classified by the US Food and Drug Administration (FDA) as a Class II recall on July 30. The butter, distributed in 500-gram blocks under the NH European Style Butter Blend label, was packed in 1,800 cases. Each case contained 36 butter blocks and was shipped to 12 distribution centres across the US and one in the Dominican Republic. The company initiated the recall on July 14. Milk not listed as ingredient Though butter is made from cream, which is derived from milk, the ingredient was not clearly mentioned on the label. Milk is considered a major allergen and must be declared under FDA regulations. The FDA defines a Class II recall as '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.' No illnesses reported yet So far, there are no reports of any allergic reactions linked to the recalled butter. However, the omission is considered serious due to the risk it poses to people with milk allergies. The FDA has advised that if someone with a milk allergy has consumed the butter and experiences symptoms, they should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention.' Live Events Understanding food allergy risks Food allergies can cause reactions ranging from mild discomfort, such as hives or swelling, to severe, life-threatening conditions like anaphylaxis . This occurs when the immune system reacts aggressively and can lead to shock if not treated promptly. To prevent such risks, the FDA mandates that food packaging must clearly state the presence of any of the eight major allergens, including milk. This recall follows another incident earlier in the week involving High Noon Hard Seltzers. A labelling error led to some vodka-containing cans being incorrectly packaged as non-alcoholic Celsius Astro Vibe Energy Drinks.

The Wire
4 hours ago
- The Wire
Concept Medical Announces First Patient Enrollment in MAGICAL-SV IDE Trial, Expanding its Coronary Clinical Program Across the U.S. and Europe
Tampa (Florida) [USA], August 4: Concept Medical Inc., a global pioneer in drug-delivery technologies, today announced the enrollment of the first patient in the MAGICAL-SV (MAGIcTouch™ Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels) trial, a U.S. Investigational Device Exemption (IDE) study evaluating its MagicTouch™ sirolimus-coated balloon (SCB) for the treatment of small coronary vessels. This first enrollment marks a major milestone in the company's mission to revolutionize coronary artery disease (CAD) treatment and expands Concept Medical's clinical program into the United States and Europe. The first patient was enrolled at Mount Sinai Hospital in New York by Dr. Samin Sharma, Director of Interventional Cardiology [KG1], marking a crucial step in advancing treatment options for patients with small-vessel coronary artery disease. 'Today marks a great feat for us and for the MAGICAL-SV trial,' said Dr. Samin Sharma. 'My team at Mount Sinai is privileged to be the first to begin this study. This is a proud moment for all of us, especially knowing what the trial signifies and aims to achieve by evaluating MagicTouchas a potential alternative for treating small vessels in the U.S.' This initial U.S. enrollment follows the FDA's IDE approval of Concept Medical's MagicTouch SCB and boosts the company's broader coronary clinical program. Concept Medical is now actively enrolling in three IDE trials concurrently in the U.S., spanning across coronary and peripheral interventions and underscoring its commitment to bringing innovative therapies to patients worldwide. MAGICAL-SV is a prospective, multicenter, single-blind randomized trial (2:1 randomization) comparing Concept Medical's MagicTouch sirolimus-coated balloon to drug-eluting stents (Everolimus eluting stents [EES] or Zotarolimus eluting stents [ZES]) for the treatment of small coronary artery lesions. Randomization is stratified by study site and presence of medically-treated diabetes mellitus status. The trial will enroll 1,605 patients across the U.S. and Europe, to evaluate the primary endpoint of target lesion failure (TLF) at 12 months. The MAGICAL-SV trial is led by an international team of renowned cardiologists, Dr. Martin B. Leon (USA) serves as Study Chair, with principal investigators (PI) Dr. Azeem Latib (USA), Dr. Ajay Kirtane (USA), and Prof. Antonio Colombo (Europe). Dr. Azeem Latib, a U.S. PI for MAGICAL-SV, noted, 'The first U.S. patient enrollment in the MAGICAL-SV study marks an exciting step forward in building robust evidence for sirolimus-coated balloon technology in the treatment of small-vessel coronary disease. As we explore metal-free PCI strategies, this study brings renewed hope for safer, more effective options for our patients.' Prof. Antonio Colombo, who leads the European arm of the study, added, 'Starting small and going big! MAGICAL-SV represents an important step in building evidence for sirolimus-coated balloons.' This milestone embodies a 'leave nothing behind' philosophy in coronary interventions, treating arterial blockages without permanent implants and addressing the limitations of metallic stents in small vessels. Dr. Martin B. Leon, the Study Chair, emphasized the significance of evaluating a no-stent strategy through this trial: 'The initiation of the MAGICAL-SV trial marks an important step in evaluating sirolimus-coated balloon therapy for small coronary vessels. By addressing key limitations of stenting in this complex anatomy, the study aims to generate strong comparative data versus DES. The results could inform future treatment strategies in the U.S. and Europe, offering clinicians a potential alternative for managing small-vessel disease.' With this pioneering trial, MAGICAL-SV is expected to yield compelling clinical evidence in support of sirolimus-coated balloon therapy. The outcomes will also support Concept Medical's Pre-Market Approval (PMA) application for the MagicTouch SCB in small-vessel indication, potentially transforming the standard of care in coronary artery disease. Dr. Manish Doshi, Founder and Managing Director of Concept Medical, said, 'At Concept Medical, our unwavering commitment to innovation and patient care drives us to push the boundaries of what is possible in vascular interventions. The initiation of MAGICAL-SV reinforces our dedication to delivering next-generation, evidence-based solutions to clinicians and patients across the globe. Our ultimate goal is to transform the current standard of care and provide better outcomes and quality of life for patients affected by CAD.' About MagicTouch SCB MagicTouch SCB is Concept Medical's sirolimus-coated balloon platform, developed with proprietary Nanoluté technology to deliver sub-micron particles of sirolimus in a biocompatible carrier for deep arterial wall penetration. The device has received CE Mark approval in Europe and a Breakthrough Device designation from the U.S. FDA for small coronary vessels and in-stent restenosis. About Concept Medical Concept Medical Inc., headquartered in Tampa, Florida, is a global leader in cutting-edge drug-delivery technologies for cardiovascular interventions. The company is dedicated to improving patient care through research and development of novel drug-delivery platforms engineered to precisely deliver therapeutic agents to diseased vascular tissue. Concept Medical's MagicTouch family of sirolimus-coated balloons is the world's first and most widely used SCB technology, recognized for its versatility, safety and efficacy in treating coronary and peripheral artery disease. The revolutionary MagicTouch and Abluminus product lines have treated over one million patients worldwide, setting a new benchmark in vascular therapy. For media inquiries, please contact: pr@ (Disclaimer: The above press release comes to you under an arrangement with PNN and PTI takes no editorial responsibility for the same.). PTI This is an auto-published feed from PTI with no editorial input from The Wire.