Breyers ice cream recalls this popular flavor due to mislabeling, allergy concern
**Related video above: Recalls: Should you be concerned?
(WJW) — With ice cream season heating up, yet another company is asking you to check your freezer for recalled treats.
Unilever is recalling nearly 7,000 cartons of Breyers Chocolate Truffle Ice Cream, according to the U.S. Food and Drug Administration. The June 2 recall took place after the company said the product was mislabeled and there were undeclared allergens.
Find out more about recalls and safety alerts right here
The move comes after Turkeyfoot Creek Creamery in Ohio recently recalled eight of its flavors and then also Wells Dairy recalled 18,000 containers of ice cream and frozen yogurt due to potential for hard plastic pieces inside.
The people at Breyers reportedly realized some containers of Chocolate Truffle Ice Cream were filled up with Rocky Road topped with a Rocky Road lid. Rocky Road, of course, has almonds, which could be harmful to those with a nut allergy. The FDA said the lid did say almonds were an ingredient.
If your 1.5-quart carton of Breyers ice cream has the UPC 077567457288, it could be affected. The FDA said the ice cream was sent to 'distribution centers and retail locations across the U.S.'
This recall was categorized as a Class II by the FDA, meaning: '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.'
'Water-resistant' spider in NE Ohio eats tadpoles, frogs, and even small fish
'People with an almond allergy should not consume the product due to risk of serious or life-threatening allergic reaction,' the company said in a statement to People. 'The safety and quality of our products is our top priority. For more information, consumers can visit www.breyers.com or call 1-800-931-2826.'
Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
New York Times
an hour ago
- New York Times
The F.D.A. Is Reviewing Infant Formula for the First Time in Decades
Last week, the Food and Drug Administration convened a panel of nutrition scientists, pediatricians and other experts to discuss the first comprehensive review of infant formula nutrient requirements since 1998. The review is part of an initiative, called 'Operation Stork Speed,' which health secretary Robert F. Kennedy Jr. announced in March to improve the safety and quality of the U.S. infant formula supply. Many health experts have applauded the effort, but some also worry that it could raise unnecessary fears that infant formulas in the United States are unsafe. In a Fox News segment last Friday, Dr. Marty Makary, the F.D.A. commissioner, implied that common ingredients in formulas, like seed oils, may be harmful to health, mentioning them alongside contaminants with known health effects like lead and arsenic. 'Moms want baby formula without seed oils, without corn syrup, without added sugar, without arsenic and lead and other heavy metals,' Dr. Makary said in the segment. We asked several scientists who specialize in infant health and nutrition to weigh in on four concerns Dr. Makary and other F.D.A. officials have raised about infant formulas in the United States. These products are safe, they said, but there are ways to make them better. Want all of The Times? Subscribe.
Indianapolis Star
an hour ago
- Indianapolis Star
Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA / ACCESS Newswire Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. 'RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV,' said Stéphane Bancel, Chief Executive Officer of Moderna. 'We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV.' While the risk of RSV is well recognized in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable. 1 Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease, 2 with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults. 3 This approval was supported by results from Moderna's Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions. The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the pivotal Phase 3, placebo-controlled safety and efficacy study. Comparable levels of neutralizing antibodies were observed across both the 18-49 and 50-59 age subgroups, supporting the vaccine's consistent immunogenicity profile in this at-risk, younger adult population. These findings were presented at the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting in April 2025 and have been published in Clinical Infectious Diseases. The vaccine was generally well-tolerated, and the most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the U.S. for the 2025-2026 respiratory virus season. About mRESVIA® (Respiratory Syncytial Virus Vaccine) mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. mRESVIA® is a registered trademark of Moderna. INDICATION mRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV). mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine. mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV. IMPORTANT SAFETY INFORMATION Who should not get mRESVIA? You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA. What should you tell your healthcare provider? Tell your healthcare provider about all of your medical conditions, including if you: Have any allergies Had a severe allergic reaction after receiving a previous dose of any other vaccine Have a fever Have a bleeding disorder or are on a blood thinner Are immunocompromised or are on a medicine that affects your immune system Have received any other RSV vaccine Have ever fainted in association with an injection How is mRESVIA given? mRESVIA is given as an injection into the muscle. What are the risks of mRESVIA? There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction may include: Trouble breathing Swelling of your face and throat A fast heartbeat A rash all over your body Dizziness and weakness Side effects that have been reported in clinical trials with mRESVIA include: Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and redness Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hives These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or Please click for mRESVIA Full Prescribing Information. Moderna Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mRESVIA; the disease burden associated with RSV, particularly in adults with certain risk factors; and the availability of mRESVIA for the 2025-2026 season. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release. Moderna Contacts Media: Chris Ridley Head of Global Media Relations +1 617-800-3651 Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 1 Prasad N, Walker TA, Waite B, et al. Respiratory syncytial virus-associated hospitalizations among adults with chronic medical conditions. Clin Infect Dis 2021; 73(1): e158-e63. 2 Wilker E, Jiang M, Francis B, et al. Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States. Poster presented at: ESCMID; April 2025; Vienna, Austria. 3 Weycker D, Averin A, Houde L, et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024; 13(1): 207-20. SOURCE: Moderna, Inc.
Yahoo
an hour ago
- Yahoo
FDA grants 510(k) clearance to Viz.ai's Viz Subdural Plus module
The US Food and Drug Administration (FDA) has granted 510(k) clearance to for its Viz Subdural Plus module, designed for enhancing clinical decision-making. It is claimed to be the first solution to quantify the size of collections such as subdural haemorrhages (SDH) in the subdural space on non-contrast computed tomography images. This solution automatically labels subdural collections and reports measurements such as thickness, midline shift, and volume. According to the company, chronic subdural haematoma is anticipated to become the most prevalent cranial neurosurgical condition in the adult population by 2030 in the US, with an estimated 60,000 new cases each year. The precise assessment of subdural collections is crucial for assessing severity, tracking progression, and guiding timely interventions, particularly for those under consideration for MMA [middle meningeal artery] embolisation. The software solution is designed to streamline the analysis of subdural collections by automating a process that has traditionally been manual and laborious. Integrated into the One platform, the software is currently in use in 1,800 health systems and hospitals. The platform enhances disease detection, supports critical care decisions, and optimises care pathways to improve patient outcomes. product management senior director Justin Ryea said: 'With an ageing population, the incidence of chronic subdural hematomas is rising, and so is the need for intelligent, automated tools to assess volume when deciding on the appropriate intervention such as MMA embolisation. 'Viz Subdural Plus, along with intracerebral haemorrhage measurements, exemplify how we're expanding our capabilities in our market-leading Viz Neuro Suite to address high-impact conditions, reduce variability in care, and drive better outcomes at scale.' The company leverages AI algorithms and machine learning to expedite diagnosis and care in the US and European healthcare systems. Last year, disclosed new trial data evaluating its AI-powered neurovascular technology that can detect and diagnose various neurological pathologies, including acute ischemic stroke, cryptogenic stroke, unruptured incidental aneurysm (UIA), and brain haemorrhage. "FDA grants 510(k) clearance to Viz Subdural Plus module" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
