Quaker Oats' recall on pancake mix elevated to highest FDA level due to risk of ‘death'
The US Food and Drug Administration (FDA) has elevated The Quaker Oats Company's recall of a pancake mix to the highest risk level.
In its latest weekly update, the FDA shared an update about a limited number of Pearl Milling Company Original Pancake & Waffle Mix boxes, which were first recalled in January because they may have contained undeclared milk.
According to a press release shared last month, the pancake mix was first available for purchase on November 18, 2024, and it was sold at retailers in 11 different states.
This recall has now received a Class I classification, meaning it's 'a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,' according to the FDA.
The Original Pancake and Waffle Mix in the recall was sold in two-pound cardboard boxes. Its UPC code is 30000 65040, and its best-by date is Sept. 13, 2025.
The mix, formerly sold as Aunt Jemima pancake mix, was sent to stores in Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Nebraska, Utah, and Wisconsin.
In its initial press release, the FDA noted that consumers with 'an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume' pancake mix. However, there haven't been any allergic reactions linked to the recalled product.
A handful of recalls have been recently classified as Class I. Earlier this month, five products from a Cal Yee Farm's recall — Yogurt Coated Almonds, Dark Chocolate Apricots, Dark Chocolate Raisins, Tropical Trail Mix, and Dark Chocolate Walnuts — were given a Class 1 classification for containing undeclared milk.
The New Orleans Hot Mix and Hot Cajun Sesame Sticks were also considered a Class 1 recall, due to undeclared wheat and soybean oil.
Last month, Bags of Lay's Classic Potato Chip received an elevated recall status, making it a Class 1. The FDA first announced in December that Frito-Lay issued a recall on a 'limited number' of the 13 oz bags of chips because they 'may contain undeclared milk.'
There's been a range of other nationwide food recalls throughout 2025. Earlier this month, 2,0176,614 cases of different baked goods from FGF, LLC were recalled due to the 'potential for contamination with listeria monocytogenes.'
Union Seafoods also recently announced a voluntary recall of select canned tuna products sold under the Genova, Van Camp's, H-E-B, and Trader Joe's brands. These products were distributed nationwide at retailers such as Walmart, Trader Joe's, Costco, Kroger, and Publix.
According to the press release, Tri-Union Seafoods initiated the recall after its supplier discovered a manufacturing defect in the tuna cans' 'easy open' lids. The defect could 'compromise the integrity of the product seal (especially over time), causing it to leak, or worse, be contaminated with clostridium botulinum,' a bacteria that causes foodborne botulism and can be fatal.
Hashtags

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


CBS News
2 hours ago
- CBS News
Breakthrough drug helps rare obesity condition, but other research uncertain amid cuts
Ali Foley Shenk still remembers the panic when her 10-year-old son, Dean, finished a 20-ounce box of raisins in the seconds the cupboard was left unlocked. They rushed to the emergency room, fearing a dangerous bowel impaction. The irony stung: When Dean was born, he was so weak and floppy he survived only with feeding tubes because he couldn't suck or swallow. He was diagnosed as a baby with Prader-Willi syndrome — a rare disorder sparked by a genetic abnormality. He continued to be disinterested in food for years. But doctors warned that as Dean grew, his hunger would eventually become so uncontrollable he could gain dangerous amounts of weight and even eat until his stomach ruptured. "It's crazy," said Foley Shenk, who lives in Richmond, Virginia. "All of a sudden, they flip." Prader-Willi syndrome affects up to 20,000 people in the U.S. The most striking symptom is its most life-threatening: an insatiable hunger known as hyperphagia that prompts caregivers to padlock cupboards and fridges, chain garbage cans, and install cameras. Until recently, the only treatment was growth hormone therapy to help patients stay leaner and grow taller, but it didn't address appetite. In March, the Food and Drug Administration approved Vykat XR, an extended-release version of the existing drug diazoxide choline, which eases the relentless hunger and may offer insights into the biology of extreme appetite and binge eating. This breakthrough for these patients comes as other drugs are revolutionizing how doctors treat obesity, which affects more than 40% of American adults. GLP-1 agonist medications Ozempic, Wegovy, and others also are delivering dramatic results for millions. But what's becoming clear is that obesity isn't one disease — it's many, said Jack Yanovski, a senior obesity researcher at the National Institutes of Health, who co-authored some of the Vykat XR studies. Researchers are learning that obesity's drivers can be environmental, familial, or genetic. "It only makes sense that it's complex to treat," Yanovski said. Obesity medicine is likely heading the way of treatments for high blood pressure or diabetes, with three to five effective options for different types of patients. For example, up to 15% of patients in the GLP-1 trials didn't respond to those drugs, and at least one study found the medications didn't significantly help Prader-Willi patients. Yet, researchers say, efforts to understand how to treat obesity's many causes and pathways are now in question as the Trump administration is dismantling the nation's infrastructure for medical discovery. While Health and Human Services Secretary Robert F. Kennedy Jr. promotes a "Make America Healthy Again" agenda centered on diet and lifestyle, federal funding for health research is being slashed, including some grants that support the study of obesity. University labs face cuts, FDA staffers are being laid off en masse, and rare disease researchers fear the ripple effects across all medical advances. Even with biotech partnerships — such as the work that led to Vykat XR — progress depends on NIH-funded labs and university researchers. "That whole thing is likely to get disrupted now," said Theresa Strong, research director for the Foundation for Prader-Willi Research. HHS spokesperson Andrew Nixon said in a statement that no NIH awards for Prader-Willi syndrome research have been cut. "We remain committed to supporting critical research into rare diseases and genetic conditions," he said. But Strong said that already some of the contacts at the FDA she'd spent nearly 15 years educating about the disorder have left the agency. She's heard that some research groups are considering moving their labs to Europe. Early progress in hunger and obesity research is transforming the life of Dean Shenk. During the trial for Vykat XR, his anxiety about food eased so much that his parents began leaving cupboards unlocked. Jennifer Miller, a pediatric endocrinologist at the University of Florida who co-led the Vykat XR trials, treats around 600 Prader-Willi patients, including Dean. She said the impact she's seen is life-changing. Since the drug trial started in 2018, some of her adult patients have begun living independently, getting into college, and starting jobs — milestones that once felt impossible. "It opens up their world in so many ways." Over 26 years in practice, she's also seen just how severely the disease hurts patients. One patient ate a four-pound bag of dehydrated potato flakes; another ingested all 10 frozen pizzas from a Costco pack; some ate pet food. Others have climbed out of windows, dived into dumpsters, even died after being hit by a car while running away from home in search of food. Low muscle tone, developmental delays, cognitive disabilities, and behavioral challenges are also common features of the disorder. Dean attends a special education program, his mother said. He also has narcolepsy and cataplexy — a sudden loss of muscle control triggered by strong emotions. His once-regular meltdowns and skin-picking, which led to deep, infected lesions, were tied to anxiety over his obsessive, almost painful urge to eat. In the trial, though, his hyperphagia was under control, according to Miller and Dean's mother. His lean muscle mass quadrupled, his body fat went down, and his bone mineral density increased. Even the skin-picking stopped, Foley Shenk said. Ali Foley Shenk (right) and her son Dean, at their home in Richmond, Virginia. Dean was born with Prader-Willi syndrome — a rare disorder that causes hyperphagia, a medical term for insatiable hunger. Since starting on a new medication as part of a clinical trial, his symptoms have improved, his mother says. Parker Michels-Boyce for KFF Health News Vykat XR is not a cure for the disease. Instead, it calms overactive neurons in the hypothalamus that release neuropeptide Y — one of the body's strongest hunger signals. "In most people, if you stop secreting NPY, hunger goes away," said Anish Bhatnagar, CEO of Soleno Therapeutics, which makes the medication, the company's first drug. "In Prader-Willi, that off switch doesn't exist. It's literally your brain telling you, 'You're starving,' as you eat." GLP-1 drugs, by contrast, mimic a gut hormone that helps people feel full by slowing digestion and signaling satiety to the brain. Vykat XR's possible side effects include high blood sugar, increased hair growth, and fluid retention or swelling, but those are trade-offs that many patients are willing to make to get some relief from the most devastating symptom of the condition. Still, the drug's average price of $466,200 a year is staggering even for rare-disease treatments. Soleno said in a statement it expects broad coverage from both private and public insurers and that the copayments will be "minimal." Until more insurers start reimbursing the cost, the company is providing the drug free of charge to trial participants. Soleno's stock soared 40% after the FDA nod and has held fairly steady since, with the company valued at nearly $4 billion as of early June. While Vykat XR may be limited in whom it can help with appetite control, obesity researchers are hoping the research behind it may help them decode the complexity of hunger and identify other treatment options. "Understanding how more targeted therapies work in rare genetic obesity helps us better understand the brain pathways behind appetite," said Jesse Richards, an internal medicine physician and the director of obesity medicine at the University of Oklahoma-Tulsa's School of Community Medicine. That future may already be taking shape. For Prader-Willi, two other notable phase 3 clinical trials are underway, led by Acadia Pharmaceuticals and Aardvark Therapeutics, each targeting different pathways. Meanwhile, hundreds of trials for general obesity are currently recruiting despite the uncertainties in U.S. medical research funding. That brings more hope to patients like Dean. Nearly six years after starting treatment, the now-16-year-old is a calmer, happier kid, his mom said. He's more social, has friends, and can focus better in school. With the impulse to overeat no longer dominating his every thought, he has space for other interests — Star Wars, American Ninja Warrior, and a healthy appreciation for avocados among them. "Before the drug, it just felt like a dead end. My child was miserable," Foley Shenk said. "Now, we have our son back." KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
Yahoo
3 hours ago
- Yahoo
Inquis Medical's AVENTUS Thrombectomy System Receives FDA 510(k) Clearance for Treatment of Pulmonary Embolism
Pioneering device combines precision clot removal with autologous blood reinfusion to address unmet needs in PE treatment MENLO PARK, Calif., June 16, 2025 (GLOBE NEWSWIRE) -- Inquis Medical, the leading innovator in the treatment of venous thromboembolic disease, today announced that its AVENTUS Thrombectomy System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for an expanded indication to treat pulmonary embolism (PE). The AVENTUS System is a next-generation mechanical thrombectomy platform developed in close collaboration with physicians to address critical limitations of current technologies. 'The FDA's clearance of the AVENTUS System marks a major milestone for the company,' said Vahid Saadat, Co-CEO of Inquis Medical. 'It validates the tireless efforts of our team and the deep partnerships we've built with our physicians, all focused on solving long-standing challenges in clot removal. AVENTUS is uniquely designed to meet the needs of physicians treating this life-threatening condition quickly, effectively, and safely.' The AVENTUS Thrombectomy System, which incorporates proprietary tissue-sensing technology to help operators distinguish the type of tissue in contact with the catheter tip in real time and guide precise clot removal, was previously cleared by the FDA for use in the peripheral vasculature. Additionally, the AVENTUS Clot Management System received FDA clearance for use with the AVENTUS Thrombectomy System to enable autologous blood transfusion, allowing reinfusion of filtered aspirated blood and supporting efficient, blood-conserving clot removal. This most recent clearance extends the platform's indication to include the treatment of pulmonary embolism. 'Treating PE requires both speed and precision,' said Mojgan Saadat, Co-CEO of Inquis Medical. 'The AVENTUS platform is the only thrombectomy solution with integrated tissue-sensing technology that enables precision removal of large clot burdens while streamlining blood return and reducing procedural complexity, all in a single, integrated approach. Receiving this clearance in record time speaks to the strength of our clinical data, the quality of our regulatory submission, and the incredible work of the Inquis team. We're thrilled to launch this technology and deliver a state-of-the-art solution to physicians on the front lines of saving lives.' This regulatory milestone follows the successful completion of the AVENTUS Pivotal Trial, the first U.S. Investigational Device Exemption (IDE) study to evaluate aspiration thrombectomy with filtered blood reinfusion in intermediate-risk PE patients. The trial demonstrated excellent safety and performance across a broad range of clinical settings, with no device-related major adverse events and rapid improvement in right heart strain. The results were presented as a late-breaking clinical trial at the 2025 Society of Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions and were simultaneously published in the society's peer-reviewed journal, JSCAI. About Inquis MedicalInquis Medical is a medical device company focused on peripheral vascular innovations. The company is developing next-generation thrombectomy technology that provides physicians with improved control and precision, enhances procedural efficiency, and minimizes blood loss. Founded in 2020, Inquis Medical is led by a seasoned executive team with decades of experience in developing, launching, and supporting novel medical devices that address unmet clinical needs and deliver lasting impact. For more information, visit our website or follow us on LinkedIn. Media Contact: John Weaverinfo@ 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
Yahoo
3 hours ago
- Yahoo
TD Cowen Affirms Buy Rating on Cardinal Health
Cardinal Health (NYSE:CAH) is . On June 10, analysts at TD Cowen reiterated a Buy rating and maintained a price target of $162 on the stock. A close-up of a person's hand holding a bottle of pharmaceuticals. The analysts expect the company to increase its long-term pharmaceutical profit guidance from 5% to 7% from a previous guidance of 4% and 6%. Cardinal Health is also expected to introduce preliminary adjusted earnings per share guidance in the range of $9.15 to $9.45. TD Cowen analyst also expects Cardinal Health to provide insights on how other segment businesses will contribute 18% of adjusted operating income. The company has entered into a distribution agreement with Citious Oncology to support the launch of FDA-approved immunotherapy LYMPHIR. Cardinal Health (NYSE:CAH) is a global healthcare company that distributes pharmaceuticals and specialty products. It also manufactures and distributes medical and laboratory products. While we acknowledge the potential of CAH as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. 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