It’s a new week and we have another food recall to bring to your attention. But this one is a repeat of sorts, so we are asking you to check your freezers, y’all.
Last October, as we previously reported, Costco issued a recall for Kirkland Signature Smoked Salmon with lot number 8512801270 and a best by date of 11/13/2024. Now, this recall has been upgraded by the FDA and given the highest level of risk, a Class 1.
The FDA defines a Class 1 recall as, “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.”
The impacted packages of salmon were manufactured by Brooklyn-based Acme Smoked Fish Corp and sold at Costco stores between October 9 and 13. And while these have long since been removed from Costco store shelves, there is concern that customers have them in their freezers and are unaware of the danger.
Consumption of food contaminated with listeria monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems can occur.
So do a sweep of the freezer and don’t take any chances. If you have one of these packages, go ahead and throw it out.
The Food and Drug Administration (FDA) has just upgraded the recall of a popular Costco grocery item to the highest alert level. Customers who have purchased this product are urged to immediately stop consuming it and return it to the store for a full refund.
The FDA has identified a potential contamination in the product that poses a serious health risk to consumers. The agency is working closely with Costco to ensure that all affected products are removed from shelves and that customers are informed of the recall.
If you have purchased this product, please check the FDA website or Costco’s official website for more information on the recall and how to return the product. Your safety is our top priority, and we apologize for any inconvenience this may cause.
Please share this post with your friends and family to help spread the word about this important recall. Thank you for your attention to this matter.
The Food and Drug Administration just raised the recall level of Lay’s Classic Potato Chips to the highest risk classification.
Frito Lay issued a recall on Dec. 16 through the FDA for over 6,000 bags of Lay’s Classic Potato Chips that contained “undeclared milk.”
According to the initial recall report, the FDA said “Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consumed the recalled product.”
On Monday, the FDA upgraded the recall to their highest classification — class 1 — which is identified as “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,” per the administration’s website.
Frito-Lay said in a statement, “This is not a new recall or a change to what was previously announced,” the statement reads. “The recall was executed in December in full cooperation with the FDA when the issue was identified. The recall was limited to two states, and recalled product has been removed from the marketplace.
The specifically recalled chips were: 13-ounce bags of Lay’s Classic Potato Chips with UPC of 28400 31041, a “Guaranteed Fresh” date of Feb. 11, 2025, and a Manufacturing Code of either 6462307xx or 6463307xx. The batch was distributed in Washington and Oregon and the chips were available for purchase as soon as Nov. 3, 2024.
What is undeclared milk?
Undeclared milk refers to milk that is present in a food product but wasn’t listed in the ingredients or label. This can happen when something is mislabeled with wrong label or a labeling error. It can also happen via cross-contamination that can occur during processing.
Milk is one of the FDA’s “Big 9” food allergens. For those that are allergic to it, milk consumption can lead to sudden, severe and potentially life-threatening allergic reactions such as hives, rash, tingling or swelling of lips, mouth, face, tongue, or throat, vomiting and/or diarrhea, cramps, coughing or wheezing, dizziness or lightheadedness, difficulty breathing, or drop in blood pressure.
What should you do if you have the recalled chips?
People who may have an allergy or sensitivity to milk should not consume the product, the alert said.
Frito-Lay is encouraging people who may have the recalled chips to throw them out immediately.
If you have any questions or concerns about this recall, you may contact Frito-Lay Consumer Relations at 1-800-352-4477 on Monday through Friday between 9 a.m. and 4:30 p.m. CT.
The Food and Drug Administration (FDA) has issued a recall on a product, raising it to the highest risk level of classification. This means that the product in question poses a serious health hazard to consumers and must be removed from shelves immediately.
If you have purchased this product, it is important to stop using it and return it to the place of purchase for a refund. The FDA has not provided specific details on the nature of the hazard, so it is crucial to heed their warning and take appropriate action.
In the meantime, be sure to check your pantry and any other storage areas for the affected product. It’s always better to be safe than sorry when it comes to potential health risks.
Stay informed by following updates from the FDA and other reputable sources to ensure the safety of you and your loved ones. Your health is the top priority, so take this recall seriously and take the necessary steps to protect yourself.
The U.S. Food & Drug Administration has recalled a popular brand of potato chips saying the product may be high risk for some consumers.
According to the recall, the 13 oz. bags of Lay’s Classic Potato Chips originally recalled in December 2023 were upgraded to the agency’s highest risk classification due to a possible undeclared milk allergen in the product. The FDA said this means “exposure or consumption of the food could cause a serious risk or life-threatening allergic reaction.”
The Class 1 recall lists products with a “guaranteed fresh” date of Feb. 11, 2025, and a manufacturing code of either “6462307xx” or “6463307xx” distributed in Oregon and Washington.
Frito-Lay said consumers who have purchased the product can contact Frito-Lay Consumer Relations at 1-800-352-4477 (9 a.m. – 4:30 p.m. CST, Monday-Friday).
Veronica Crespo writes for Local10.com and also oversees the Español section of the website. Born and raised in Miami, she graduated from the University of Miami, where she studied broadcast journalism and Spanish.
Recently, the FDA issued a recall on certain Lay’s potato chips that are considered ‘high risk’ due to potential contamination. The recall affects specific batches of Lay’s potato chips that have been found to contain harmful bacteria or foreign objects.
Consumers are urged to check their packaging for the affected codes and to immediately stop consuming the chips if they match the criteria for the recall. The FDA has advised that consuming these ‘high risk’ Lay’s potato chips could lead to serious health complications, so it is crucial to take this recall seriously.
If you have purchased Lay’s potato chips recently, be sure to check the packaging for any signs of contamination and follow the FDA’s guidelines for handling the affected products. Your health and safety are of the utmost importance, so it is important to stay informed and take the necessary precautions.
Frito-Lay has recalled its Lay’s Classic Potato Chips in Oregon and Washington state due to undeclared milk that may be in the product that could be fatal if consumed by someone with an allergy or severe sensitivity to milk.
The Food and Drug Administration announced last month a recall of a limited number of 13 oz. bags of Lay’s Classic Potato Chips over concerns that the product may contain undeclared milk. No other Lay’s products, flavors, sizes or variety packs have been recalled.
“Those with an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume the recalled product,” the FDA said on Dec. 16.
Lay’s potato chips pack seen in a Target superstore. (Alex Tai/SOPA Images/LightRocket via Getty Images / Getty Images)
On Monday, the FDA updated its guidance, classifying it under a Class 1 recall — its highest risk classification — which means exposure or consumption of the chips could cause “serious adverse health consequences or death,” according to Newsweek.
The chips were given the high level classification because milk is one of the FDA’s eight “major food allergens,” which means it is one of the products that can lead to hives, cramps, dizziness, swollen vocal cords and even unconsciousness if someone with an allergy or severe sensitivity to milk consumes it.
Consumers would have been able to purchase these chips in Oregon and Washington state as early as November 3. The recalled chips were distributed to certain retail stores and e-commerce distributors.
Frito-Lay potato chip snacks in a supermarket in New York on Thursday, February 12, 2015. (Getty Images / Getty Images)
Anyone in the two states with Lay’s chips that have both a “guaranteed fresh” date of February 11 and a manufacturing code of either “6462307xx” or “6463307xx” should discard the chips immediately, especially if someone in their household has a milk allergy.
Frito-Lay said it was alerted to the undeclared milk after being contacted by a customer.
The company said no allergic reactions related to this recall have been reported.
Lay’s Recall of Classic Chips in 2 States Classified at Highest Risk Level, FDA Warns it Could Cause ‘Death’
The Food and Drug Administration (FDA) has issued a warning about a recent recall of Lay’s classic potato chips in two states, citing a potential risk of death for consumers who may have consumed the affected products.
The recall, which was initiated by Lay’s parent company, Frito-Lay, applies to certain batches of Lay’s classic potato chips that were distributed in California and Texas. The products in question have been classified at the highest risk level, indicating a serious health hazard for consumers.
According to the FDA, the recall was prompted by the detection of a harmful bacteria in the affected batches of Lay’s classic potato chips. The bacteria, which has not been named, is known to cause severe illness and can be fatal in some cases.
Consumers who have purchased Lay’s classic potato chips in California or Texas are urged to check their packaging for the specific batch numbers listed in the FDA’s recall notice. If they have consumed any of the affected products, they are advised to seek medical attention immediately.
Frito-Lay has stated that it is working closely with the FDA to investigate the source of the contamination and to implement measures to prevent similar incidents in the future. In the meantime, the company has assured consumers that it is committed to ensuring the safety and quality of its products.
For more information about the Lay’s recall and to check if your product is affected, visit the FDA’s website or contact Frito-Lay’s customer service hotline. Stay safe and stay informed.
Today the FDA announced that it had expanded semaglutide’s (Ozempic; Novo Nordisk) indications to include patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The move means the drug is the sole glucagon-like peptide-1 receptor agonist (GLP-1 RA) approved for mitigating cardiovascular (CV) risks and kidney disease that has advanced—when added to standard care—in this patient population. This decision was informed by the FLOW (NCT03819153) phase 3b kidney outcomes trial, which found a correlation between once-weekly injections of semaglutide and a subsequently reduced risk of both cardiovascular disease (CVD) and adverse kidney outcomes.1
For the FLOW trial, those in the treatment group exhibited a statistically significant 24% risk decrease for multiple adverse kidney outcomes, including progressive and end-stage kidney disease, as well as a nearly 5% risk decrease for CVD-related death at 3 years compared with the placebo group. | image credit: cartoon – stock.adobe.com
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated,” Anna Windle, PhD, senior vice president, Clincal Development, Medicat & Regulatory Affairs, Novo Nordisk, said in a statement.
Semaglutide received its first FDA approval back in 2017; at the time, it was only indicated for T2D to improve patients’ glucose and was recommended alongside exercise and dietary modifications. By 2020, semaglutide’s indication was expanded to include patients with T2D and forms of heart disease to mitigate their risks for stroke, heart attack, other CV episodes, or death.
CKD poses an additional risk for patients with T2D, occurring in around 40% of this population, and can influence the likelihood of developing CV issues and individual mortality risks. Diabetes itself remains a primary driver of CKD. As the aging population is expected to grow, data project a rising incidence of diabetes that could, in turn, result in a greater rates of kidney failure and CKD.2
“A large portion of patients I treat experience serious kidney complications and comorbidities, with some even requiring dialysis. Today’s decision by the FDA offers hope for the millions of adults living with both conditions and provides an additional treatment option, representing a significant advancement for my patients,” Richard E. Pratley, MD, medical director, AdventHealth Diabetes Institute located in Orlando, Florida, noted in a statement.1
The FLOW phase 3b kidney outcomes trial compared the efficacy of semaglutide 1 mg with a placebo, with one of the primary outcomes of interest being achieving and sustaining at least a 50% reduction in estimated glomerular filtration rate (eGFR), as well as an eGFR less than 15 mL/min/1.73 m2. Outcomes related to CV or renal death, as well as chronic renal replacement therapy, were additional primary end points. The study population comprised 1767 adults with T2D and CKD in the semaglutide group and 1766 adults with T2D and CKD in the placebo group. Patients were featured from 28 countries, with the trial being conducted across an estimated 400 sites.
Those in the treatment group exhibited a statistically significant (P < .05) 24% risk decrease for multiple adverse kidney outcomes, including progressive and end-stage kidney disease, as well as a nearly 5% risk decrease for CVD-related death at 3 years compared with the placebo group.
“With this new indication, Ozempic stands out uniquely as the most broadly indicated GLP-1 RA in its class. We are proud to continue advancing innovations that will have a meaningful impact for this patient population, underscoring Novo Nordisk’s commitment to cardiometabolic care,” Wilde commented.
The FDA has recently expanded the use of semaglutide, a medication commonly used to treat type 2 diabetes, to also include reducing the risk of cardiovascular events and kidney disease in patients with type 2 diabetes and chronic kidney disease.
This decision comes after the results of a large clinical trial showed that semaglutide significantly reduced the risk of major cardiovascular events such as heart attack and stroke, as well as the progression of kidney disease in patients with type 2 diabetes and chronic kidney disease.
Semaglutide works by increasing insulin production in the body and decreasing the production of glucose in the liver, helping to lower blood sugar levels in patients with type 2 diabetes. In addition to its benefits for controlling blood sugar levels, semaglutide has now been shown to also reduce the risk of serious complications such as heart disease and kidney disease in these patients.
This expanded use of semaglutide provides a new treatment option for patients with type 2 diabetes and chronic kidney disease who are at risk for these serious complications. Patients should consult with their healthcare provider to determine if semaglutide is the right treatment option for them.
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the US Food and Drug Administration to reduce certain risks associated with chronic kidney disease, drugmaker Novo Nordisk said Tuesday.
A Phase 3 clinical trial found that injections of the semaglutide medication once weekly reduced the risk of kidney disease worsening by 24% in people who also had diabetes. It also reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both type 2 diabetes and chronic kidney disease, the company said in a news release.
Chronic kidney disease is a common complicationfor people living with type 2 diabetes. Diabetes is the leading cause of kidney failure, which is one of the leading causes of death in the US and worldwide; about a third of adults with diabetes also have chronic kidney disease, according to the US Centers for Disease Control and Prevention
The clinical trial tested the efficacy of Ozempic when added to the standard of care, not as a replacement for other treatments for disease management such as medicines to manage blood pressure, including ACE inhibitors and ARBs. About 3,500 adults across 28 countries were enrolled in the trial, which started in 2019 and followed participants for an average of about 3½ years.
The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.
Novo Nordisk is conducting a different study to understand how and why semgalutide seems to reduce the progression of kidney disease, said Stephen Gough, global chief medical officer and senior vice president at Novo Nordisk. But even though scientists don’t fully understand the mechanisms behind them, the positive effects are strong: The clinical study was stopped early after reaching positive endpoints sooner than expected, and no new safety risks were identified in this trial, he said.
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“This really means something to the patients,” Gough told CNN. “The impact on not just kidney disease but also cardiovascular disease and on all-cause death.”
Ozempic and other semaglutide injections such as Wegovy have been in short supply for years due to their rapid popularity. The FDA now lists Ozempic as “available,” but there is still high demand.
“This is a medicine that’s already available, both in diabetes clinics and now in renal clinics, so I would hope the uptake would start pretty quickly,” Gough said, adding that he hopes the confidence that comes with the data behind this approval will aid clinicians who are making daily decisions about how and when to use different treatments.
“It does help clinicians with their decision-making process, and it helps them focus those medicines to the patients who will benefit the most,” he said.
The FDA has recently approved the use of Ozempic for reducing the risks associated with chronic kidney disease in patients with diabetes. This is a significant development in the field of diabetes management, as chronic kidney disease is a common complication of diabetes and can lead to serious health issues if not properly addressed.
Ozempic, also known as semaglutide, is a once-weekly injectable medication that helps lower blood sugar levels in patients with type 2 diabetes. In addition to its blood sugar-lowering effects, studies have shown that Ozempic can also help reduce the risk of kidney damage in diabetic patients.
Chronic kidney disease is a serious complication of diabetes that can lead to kidney failure if not properly managed. By reducing the risks associated with kidney disease, Ozempic has the potential to improve the overall health and quality of life for diabetes patients.
The approval of Ozempic for reducing the risks of chronic kidney disease in diabetes patients is a significant milestone in the field of diabetes management. It provides healthcare providers with another tool to help prevent and manage complications associated with diabetes, ultimately improving patient outcomes and quality of life.
The Food and Drug Administration on Tuesday approved Novo Nordisk‘s Ozempic to treat chronic kidney disease in patients who also have Type 2 diabetes, expanding the use of the wildly popular injection in the U.S.
The drug is already widely used and covered to treat Type 2 diabetes. The FDA’s decision means Ozempic can now be used to reduce the risk of kidney disease worsening, kidney failure, and death from cardiovascular disease in patients with both chronic kidney disease and diabetes.
The decision could transform how doctors treat patients with chronic kidney disease, which involves a gradual loss of kidney function and is one of the leading causes of death in the U.S. Around 37 million American adults are living with chronic kidney disease, according to Novo Nordisk.
Diabetes is a key risk factor for kidney disease. Roughly 40% of Type 2 diabetes patients have the condition, which can cause additional sickness such as increased risk of cardiovascular problems and death, Novo Nordisk said.
“All chronic kidney disease is progressive. It’s a year-on-year, relentless decline in renal function,” Stephen Gough, Novo Nordisk’s global chief medical officer, said in an interview, referring to the kidney’s ability to filter waste from the blood.
He noted that when the condition progresses to the point of kidney failure — also known as end-stage kidney disease — patients require long-term dialysis treatments to remove waste from the blood, or a kidney transplant. Both are burdensome, and death among patients with end-stage kidney disease is “very high,” particularly from cardiovascular disease, according to Gough.
The approval also demonstrates that a blockbuster class of diabetes and weight loss drugs called GLP-1s have significant health benefits beyond regulating blood sugar and suppressing appetite.
Ozempic reduced the risk of severe kidney outcomes — including kidney failure, reduction in kidney function, or death from kidney or heart causes — by 24% in diabetic patients with chronic kidney disease compared with a placebo, according to results of a late-stage trial that the approval was based on.
In patients who took Ozempic, kidney function declined more slowly, the risk of major cardiovascular events such as heart attack dropped 18% and the risk of death from any cause fell 20% compared with the placebo. Ozempic also cut the risk of cardiovascular-related deaths by 29%.
“We know that, unfortunately, cardiovascular disease and chronic kidney disease just go hand in hand,” Gough said.
He added that the major treatments patients typically receive when they have the earliest signs of chronic kidney disease aim to reduce cardiovascular risk factors by paying attention to blood pressure.
The rate of serious adverse side effects was 49.6% in patients who took Ozempic, lower than the 53.8% seen in the group that received a placebo. There was a slightly higher rate of discontinuations among Ozempic patients due to gastrointestinal side effects commonly seen with GLP-1s, such as nausea and vomiting.
EU regulators approved Ozempic for the same use in December.
Novo Nordisk ended the phase three trial in October, a year earlier than expected, in response to positive results. At the time, the Danish company’s announcement caused shares of kidney dialysis companies to plummet about 20% in a single day.
The trial, called FLOW, started in 2019 and followed roughly 3,500 patients with diabetes and moderate to severe chronic kidney disease.
“From my point of view as a doctor, you don’t get [diabetes, obesity, chronic kidney disease and cardiovascular disease] in isolation,” Gough said. “These illnesses, unfortunately, co-segregate. They cluster within the same individuals. So if you have a medicine that can target each of these co-morbidities in one injection, then you’re addressing what really matters to the patient.”
The approval comes after the Biden administration selected three of Novo Nordisk’s drugs with the active ingredient semaglutide for the second cycle of Medicare drug price negotiations. That includes Ozempic, its weight loss counterpart Wegovy and another diabetes treatment called Rybelsus.
The FDA’s decision also comes as Novo Nordisk faces increased competition from Eli Lilly and tries to win expanded insurance coverage for Wegovy.
Last year, Wegovy won approval in the U.S. for use in slashing the risk of major cardiovascular events such as heart attacks and strokes. Novo Nordisk is also studying Wegovy as a potential treatment for fatty liver disease.
Novo Nordisk’s Ozempic has just received FDA approval for the treatment of chronic kidney disease, marking a major milestone for the company and potentially changing the landscape of treatment options for patients with this condition.
Chronic kidney disease affects millions of people worldwide and can lead to serious complications if left untreated. With the approval of Ozempic, patients now have a new option for managing their condition and potentially improving their quality of life.
Ozempic is already approved for the treatment of type 2 diabetes, and this new indication expands its potential impact on patients with chronic kidney disease. The drug works by helping the body regulate blood sugar levels and improve kidney function, offering a comprehensive approach to managing this complex condition.
Novo Nordisk is known for its commitment to developing innovative treatments for chronic diseases, and the approval of Ozempic for chronic kidney disease is a testament to their dedication to improving patient outcomes. This news is sure to be welcomed by patients, healthcare providers, and investors alike.
Overall, the approval of Ozempic for chronic kidney disease represents a significant advancement in the field of medicine and offers hope for those affected by this condition. It will be interesting to see how this new treatment option impacts the lives of patients and the future of kidney disease management.
Lay’s potato chips have been recalled across two states, and the FDA has set its highest risk level for the recalled chips.
The Food and Drug Administration (FDA) recalled 6,344 bags of Lay’s Classic Potato Chips across Oregon and Washington on December 13, and gave their risk classification on January 27.
Why It Matters
The chips have been classified under a Class 1 recall, meaning, per the FDA, exposure or consumption of the chips could cause “serious adverse health consequences or death.”
In this case, they were given this high classification because the chips contained undeclared milk. Milk is one of the FDA’s eight “major food allergens,” meaning it is one of the food products that can lead to hives, cramps, dizziness, swollen vocal cords, and even unconsciousness among those who are allergic to it.
What To Know
The recall was voluntarily initiated by Lay’s in December across Washington and Oregon retail and e-commerce outlets.
The company said it was alerted to the undeclared allergen after being contacted by a customer. Lay’s also said that its 13 oz. bag of classic chips was the only type of chip being recalled. All other Lay’s chips are safe to eat.
The FDA recalled six other products in January so far which involved undeclared milk, and 10 total products so far which contained undeclared allergens.
The products with undeclared milk were several NuGo granola bars which were recalled on January 10; Pancake and Waffle Mix from Pearl Milling Company, which were recalled on January 15; Monkfish Liver from New York Mutual Trading Co., which was recalled on January 16; barbecue sauces from Monkey Spit, which were recalled on January 16 and which also contained undeclared wheat and soy; and Snack foods-Corn Puffs from Shirakiku, which were recalled on January 20.
On January 7, Premium Home-Style Mashed Potatoes from Dierbergs Kitchen were recalled for containing undeclared wheat. On January 10, My Mochi Peach Mango Sorbets were recalled for containing undeclared egg. On January 21, “Colussi Cantuccini Chocolate Drops” chocolate chip cookies from Colussi were recalled for undeclared almonds, and earlier in January, bacon flavor popcorn seasoning from Wabash Valley Farms, Rural King were recalled for “Potential or Undeclared Allergen—soy.”
What People Are Saying
Frito Lay’s in a December 16 press release: “No allergic reactions related to this matter have been reported to date. No other Lay’s products, flavors, sizes or variety packs are recalled.”
Frito Lay’s in a statement provided to Newsweek: “Frito-Lay issued a recall for a limited number of 13 oz. bags of Lay’s Classic Potato Chips that may contain undeclared milk. The product included in this recall was distributed in Oregon and Washington. No other Lay’s products, flavors, sizes or variety packs are recalled.”
What Happens Next
Anyone in Washington or Oregon with Lay’s chips that have both a “guaranteed fresh” date of February 11, and a manufacturing code of either “6462307xx” or “6463307xx” should dispose of those chips immediately, especially if someone in your household has a milk allergy.
Attention all snack lovers: Lay’s Potato Chips have been recalled due to a potential health risk identified by the FDA. The agency has set the highest risk level for this recall, indicating a serious concern for consumers.
If you have purchased Lay’s Potato Chips recently, please check the packaging for any signs of the recall. It is important to take this warning seriously and refrain from consuming any affected products.
Stay informed and stay safe, snackers. Your health is always the top priority. #LaysPotatoChipsRecall #FDAWarning #SnackSafety
Broth sold in Walmart in nine U.S. states has been recalled and given a “Class II” risk level by the Food and Drug Administration (FDA).
Great Value Chicken Broth was recalled by TreeHouse Foods, Inc., British Columbia, Canada, due to potential for packaging failures that could compromise the sterility of the product, resulting in spoilage.
The recall was initiated on December 11, 2024, and the risk classification was set on Tuesday, January 21, 2025.
According to the FDA’s website, a “Class II” recall means: “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.”
Newsweek has approached TreeHouse Foods for comment via email.
If packaging is compromised, bacteria, yeasts and molds can contaminate food products, compromising quality and safety.
Sometimes we can tell that food has spoiled, from how it looks, tastes or feels in our mouths, but other times differences may be undetectable but still potentially harmful.
The broth was sold in Walmart stores in nine U.S. states: Alabama, Arkansas, Georgia, Louisiana, Missouri, Mississippi, Oklahoma, Tennessee and Texas.
The broth had “best if used by” dates of March 25, 2026, and the lot code “98F09234” printed on the packaging.
There were two possible—almost identical—unique product codes (UPC) too; the retail unit UPC was “007874206684” and the case UPC was “078742066844.”
This is not the only recall recently issued by TreeHouse Foods. Various gluten-free organic waffles, sold under Nature’s Path brand but manufactured by Tree House Foods, were recalled in October.
This is because the waffles may have been contaminated with Listeria monocytogenes, bacteria that can cause serious or life-threatening infections in some people.
A spokesperson for TreeHouse Foods previously told Newsweek in an email: “In October 2024, TreeHouse Foods announced a voluntary recall of all griddle products manufactured at our Brantford, Ontario, Canada facility.
“The frozen toaster waffle, Belgian waffle and pancake products were recalled due to the potential to be contaminated with Listeria monocytogenes.
“We have no confirmed reports of illness or injury linked to the recalled products. As of January 2025, the Brantford facility has undergone a hygienic restoration and is once again producing griddle products for our customers.”
Sriracha chili sauce was recalled in December by Mr. Bing Foods Inc. over fears the hot sauce had been contaminated with spoilage organisms.
Do you have a tip on a food story that Newsweek should be covering? Is there a nutrition concern that’s worrying you? Let us know via science@newsweek.com. We can ask experts for advice, and your story could be featured in Newsweek.
Attention Walmart shoppers, an update on the recent broth recall has been released by the FDA. The FDA has officially set a risk level for the recalled broth products sold at Walmart stores.
Customers who have purchased any broth products from Walmart are urged to check the FDA website for a list of the specific products affected by the recall. The FDA has determined that these products pose a potential health risk due to contamination issues.
It is important to note that Walmart is working closely with the FDA to ensure the safety of its customers. The company is taking all necessary steps to remove the recalled products from shelves and provide refunds to affected customers.
We encourage all Walmart shoppers to stay informed and take necessary precautions to protect their health and safety. Stay tuned for further updates on this developing situation.
This photo provided by Janssen Global Services shows Spravato nasal spray.
Janssen Global Services via AP
The Food and Drug Administration on Tuesday approved Johnson & Johnson‘s nasal spray to be used alone in adults with a major depressive disorder that is difficult to treat, as sales of the drug grow.
The spray, called Spravato, is now the first-ever stand-alone therapy for treatment-resistant depression, which is when trying at least two standard treatments does little to nothing to improve depression symptoms in a patient.
Previously, Spravato was cleared in the U.S. to use together with an oral antidepressant for both treatment-resistant depression and for people with major depressive disorder who are experiencing thoughts of suicide or harm. The drug first entered the U.S. market in 2019.
“We want to recognize that this is a medicine that treats a disease that [when] left untreated, depression is potentially fatal,” Bill Martin, J&J’s global therapeutic area head of neuroscience, said in an interview.
Around one-third of the estimated 21 million U.S. adults with major depression battle symptoms — such as persistent feelings of sadness, sleep disturbances, low energy, and thoughts of death or suicide — that don’t respond to treatment, according to some estimates.
“For the first time ever, we now have an option that gives patients freedom,” said Dr. Gregory Mattingly, a physician and president of the Midwest Research Group who was involved in Spravato’s original clinical trials.
His center in St. Louis has treated more than 6,000 patients with the drug, and currently just over 100 people are taking it there. That is one of 3,000 outpatient treatment centers in the U.S. that are certified to administer Spravato, according to J&J’s tally.
Mattingly said patients can now choose to take Spravato with or without an oral antidepressant, especially if those pills aren’t improving their symptoms and are causing undesirable side effects, such as weight gain and sexual issues.
J&J’s Martin said the approval provides “an avenue for caregivers and their patients to really optimize, personalize the treatment paradigm for each individual” and determine the best way for them to manage the disease.
That could potentially “open up the number of patients who could benefit” from Spravato, according to Martin.
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Spravato is on its way to becoming a blockbuster product, with the drug bringing in $780 million in sales during the first nine months of 2024 as doctors grow more comfortable using it, according to J&J’s third-quarter earnings. The company has even higher expectations for its growth, telling investors in December that it expects sales will increase to between $1 billion and $5 billion annually.
That is a boon to J&J as it prepares for an upcoming patent expiration and new negotiated prices with Medicare to pressure sales of its top-selling inflammatory treatment, Stelara.
The approval is based on a phase four trial, which showed Spravato alone improved depressive symptoms beginning about 24 hours after treatment and lasting through at least one month. The company has said that the safety profile was consistent with previous clinical data on Spravato’s use in combination with oral antidepressants.
Martin said that demonstrates “not only rapid symptom relief, but also a durable symptom relief” when patients take Spravato by itself.
Spravato’s long road to rapid growth
Spravato blazed a trail in 2019 as the first new major depression treatment to win FDA approval in more than three decades. The drug is related to ketamine, a common anesthetic that can have hallucinogenic effects and is sometimes misused recreationally. J&J made it into a nasal spray to get it into the brain quickly.
Spravato “turns on neural networks in a way that’s different,” said Mattingly.
“Our standard oral antidepressants took weeks to months to see if they’re going to work,” he added. “Quite often with the same day, the very next day, people can already start to feel they’re feeling somewhat better” with Spravato.
Spravato’s warning label cautions about the risk of sedation and dissociation, respiratory depression, suicidal thoughts, and abuse or misuse of the drug, among other potential side effects. Because of that, Spravato is only available through a restricted program, meaning it can’t be purchased at a pharmacy and is only administered in certified health-care settings under strict supervision.
Users of the medication must also be monitored by a health-care professional for two hours following administration.
Spravato’s launch had a sluggish start, especially as pandemic-related challenges complicated arrangements for the drug’s necessary medical supervision. But J&J began to market Spravato more heavily after in-person doctor visits became the norm again, and physicians became more aware of its benefits.
“The mental health community wasn’t really used to doing procedures at that point. We weren’t used to having a space set aside. We weren’t used to thinking about how to do Spravato,” Mattingly said. “I think the good news is now we’ve all seen the benefits to our patients. So many of us have become really strong advocates” for it.
Five years of real-world data on the drug and a head-to-head study demonstrating Spravato’s superior efficacy to an oral antidepressant also gave doctors higher confidence in the treatment, according to J&J’s Martin.
If you are having suicidal thoughts or are in distress, contact the Suicide & Crisis Lifeline at 988 for support and assistance from a trained counselor.
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Great news for those struggling with treatment-resistant depression! The FDA has recently approved Johnson & Johnson’s nasal spray called Spravato for use in patients with depression. This new medication offers hope for individuals who have not found relief with traditional antidepressants.
Spravato, which contains the active ingredient esketamine, has shown promising results in clinical trials for its ability to rapidly reduce symptoms of depression. This breakthrough treatment is administered under the supervision of a healthcare provider and has been found to be effective in improving mood and overall well-being.
If you or someone you know is dealing with treatment-resistant depression, be sure to speak with a healthcare provider about the potential benefits of Spravato. This new nasal spray could be a game-changer in the treatment of depression and offer new hope for those in need.
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