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Tag: FDA

Quaker Oats Company recalls Pearl Milling pancake, waffle mix: FDA

New Yorkers are feeling the pinch in their pocketbooks after a listeria outbreak has affected 7 million pounds of cold cuts. (Credit: WNYW)

Officials from the Food and Drug Administration (FDA) recently escalated the recall of certain Quaker Oats pancake mixes earlier this week, increasing the recall category to the most serious level.

The Quaker Oats Company, a subsidiary of Pepsi Co, previously announced the limited recall of certain boxes of Pearl Milling Company Original Pancake & Waffle Mix on Jan. 14. Pearl Milling was originally branded as Aunt Jemima before 2021.

On Thursday, the FDA updated the recall category to Class I, which pertains to “situation[s] 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.”

In a January press release, the company noted that certain two-pound boxes of the product contained “undeclared milk.”

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A Quaker Oats Company product is being recalled by the FDA. (Gabby Jones/Bloomberg via Getty Images / Getty Images)

“[The recall was announced] after being alerted by a retail partner,” the statement noted. “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 mixes were distributed to retailers in 11 states: Arkansas, Illinois, Indiana, Iowa, Kansas, Kentucky, Minnesota, Mississippi, Nebraska, Utah and Wisconsin. Consumers could have bought the recalled products as early as Nov. 18 of last year.

No other Pearl Milling pancake and waffle mixes have been recalled, and the recall strictly pertains to products with a UPC code of 30000 65040 and a best-by date of Sept. 12, 2025.

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Aunt Jemima logo updated to Pearl Milling Company, Quaker Oats stated old logo was based on a racial stereotype. (Lindsey Nicholson/Universal Images Group via Getty Images / Getty Images)

“No allergic reactions related to this matter have been reported to date,” the company noted. “If consumers have an allergy or sensitivity to milk, they should not consume the product and discard it immediately.”

Quaker Oats has recalled multiple products in the past few years. In December 2023, Quaker Oats recalled over two dozen types of granola bars and cereals due to a salmonella contamination risk.

In March 2021, the company recalled thousands of bags of its Quaker Rice Crisps Sweet Barbecue Flavor over the possibility of undeclared soy.

Consumers are urged to check their pancake boxes to see if their products are included in the recall. (iStock / iStock)

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FOX Business reached out to Quaker Oats for additional comment.

February 15, 2025
Trump NIH and FDA nominees debut new scientific journal aimed at spurring debate

President Donald Trump’s nominees to run the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are part of a group of scientists who just launched a new research journal focused on spurring scientific discourse and combating “gatekeeping” in the medical research community.

The journal, titled the Journal of the Academy of Public Health (JAPH), includes an editorial board consisting of several scientists who complained of facing censorship during the COVID-19 pandemic.

JAPH’s co-founders include Martin Kulldorff, a former Harvard Medical School professor who is a founding fellow at Hillsdale College’s Academy for Science and Freedom, and Dr. Jay Bhattacharya, a professor of health policy at Stanford University who is also Trump’s nominee to be the next NIH director. Kulldorff and Bhattacharya became known during the pandemic for authoring The Great Barrington Declaration, which sought to challenge the broader medical community’s prevailing notions about COVID-19 mitigation strategies, arguing that – in the long run – the lockdowns that people were facing would do more harm than good.

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Dr. Marty Makary, a surgeon and public policy researcher at Johns Hopkins University, who is Trump’s nominee to be the next director of the FDA, is on the journal’s editorial board as well.

Stanford’s Dr. Jay Bhattacharya, left, appears alongside Johns Hopkins University’s Dr. Marty Makary. (Getty Images/Fox News)

JAPH is adopting a novel approach by publishing peer reviews of prominent studies from other journals that do not make their peer reviews publicly available. The effort is aimed at spurring scientific discourse, Kulldorff said in a paper outlining the purposes of the journal’s creation.

The journal will also seek to promote “open access” by making all of its work available to everyone in the public without a paywall, he said, and the journal’s editorial leadership will allow all scientists within its network to “freely publish all their research results in a timely and efficient manner,” to prevent any potential “gatekeeping.”

“Scientific journals have had enormous positive impact on the development of science, but in some ways, they are now hampering rather than enhancing open scientific discourse,” Kulldorff said. “After reviewing the history and current problems with journals, a new academic publishing model is proposed – it embraces open access and open rigorous peer review, it rewards reviewers for their important work with honoraria and public acknowledgment and it allows scientists to publish their research in a timely and efficient manner without wasting valuable scientist time and resources.”

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Kulldorff, Bhattacharya, Makary and others on the new journal’s leadership team have complained that their views about the COVID-19 pandemic were censored. These were views that were often contrary to the prevailing ideas put forth by the broader medical community at the time, which related to topics such as vaccine efficacy, natural immunity, lockdowns and more.

(Censorship was a common complaint from medical researchers like Dr. Jay Bhattacharya, Dr. Marty Makary and Dr. Martin Kulldorff, who were among the few scientists who promoted ideas like herd immunity and challenged the efficacy of lockdowns and vaccine mandates.)

“Big tech censored the [sic] all kinds of science on natural immunity,” Makary said in testimony to Congress following the pandemic. During his testimony, Makary also shared how one of his own studies at Johns Hopkins during the pandemic that promoted the effectiveness of natural immunity, which one scientific journal listed as its third most discussed study in 2022, “was censored.”

“Because of my views on COVID-19 restrictions, I have been specifically targeted for censorship by federal government officials,” Bhattacharya added in his own testimony to Congress the same year.

Kulldorff, who has also complained about censorship of his views on COVID-19, argued he was asked to leave his medical professorship at Harvard that he held since 2003, for “clinging to the truth” in his opposition to COVID-19 lockdowns and vaccine mandates.

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Dr. Martin Kulldorff is a former Harvard Medical School professor. (Getty Images)

“The JAPH will ensure quality through open peer-review, but will not gatekeep new and important ideas for the sake of established orthodoxies,” Andrew Noymer, JAPH’s incoming editor-in-chief told Fox News Digital.

“To pick one example, in my own sub-field of infectious disease epidemiology, we have in the past few years seen too little published scholarship on the origins of SARS-CoV-2, the virus that causes COVID. Academic publishing as it exists today is too often concerned with preservation of what we think we know, too often to the detriment of new ideas.”

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Bhattacharya and Makary did not wish to comment on this article.

February 11, 2025
FDA escalates Walmart broccoli recall

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A recall over Walmart-sold broccoli florets has been escalated to Class I, the highest threat level, as consumers are warned to discard the food products over potential contamination.

Braga Fresh has been recalling some packages of its ready-to-eat 12oz Marketside Broccoli Florets since Dec. 27. The FDA announced the recall on Dec. 31 and recently upgraded its classification.

Class I recalls, which are the most serious category of FDA food recalls, refer to “situation[s] 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 recall only pertains to 12oz bags of Marketside Broccoli Florets sold at Walmart stores. The recalled products have a UPC code of “6 81131 32884 5” on the back of the bag, and a best-by date of Dec 10, 2024. The products also contain a a lot code of “BFFG327A6”.

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Braga said sales of the broccoli florets occurred at Walmart stores in 20 states. (Food and Drug Administration)

“All potentially affected products are past their expiration date and no longer for sale,” the Braga Foods statement read. “This voluntary advisory does not apply to any other Marketside or Braga Fresh produced products.”

“This product is past its [best-by date] and is no longer in stores, but consumers may have frozen the item for later use,” the release added. “Consumers who have this product in their freezers should not consume and discard the product.”

According to the statement, the recall was initiated “due to possibility of contamination with Listeria monocytogenes.”

“The potential for contamination was discovered during random sampling by Texas Health & Human Services from a Texas store location where one of multiple samples yielded a positive test result,” the statement read.

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A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland. (Sarah Silbiger/Getty Images / Getty Images)

The Walmart locations that received the potentially affected product are located in Alaska, Arkansas, Arizona, California, Colorado, Idaho, Illinois, Indiana, Kentucky, Louisiana, Michigan, Montana, Nevada, Ohio, Oklahoma, Oregon, Texas, Utah, Washington and Wyoming.

Though no illnesses have been reported in connection to the products, Listeria monocytogenes can lead to listeriosis, which is especially deadly to pregnant women, older adults and people with weakened immune systems.

“Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women,” the FDA said in a statement.

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A Walmart store in Secaucus, New Jersey, US, on Friday, Nov. 24, 2023. (Victor J. Blue/Bloomberg via Getty Images / Getty Images)

FOX Business reached out to Braga Foods and Walmart for comment.

FOX Business’ Aislinn Murphy contributed to this report.

February 2, 2025
Vertex Pharmaceuticals’ non-opioid pain medication gets FDA approval

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A non-opioid pain medication made by Vertex Pharmaceuticals has received approval for adults from the Food and Drug Administration (FDA).

The company’s “first-in-class” suzetrigine pain pill received the green light for treating moderate to severe acute pain in adults on Thursday, the federal agency said.

The medication reduces pain “by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain,” according to the FDA.

Vertex Pharmaceuticals’ logo on a smartphone. (Pavlo Gonchar/SOPA Images/LightRocket via Getty Images / Getty Images)

It will use Journavx as its brand name.

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Vertex CEO Reshma Kewalramani touted Journavx as the “first new class of pain medicine approved in more than 20 years,” adding that the company has the “opportunity to change the paradigm of acute pain management and establish a new standard of care.”

The medication resulted in a “statistically significant” reduction in pain versus a placebo within two days for patients in a pair of trials who had received abdominoplasties and bunionectomies, according to Vertex. The trials were randomized, double-blind, placebo-controlled and active-controlled.

“A new non-opioid analgesic therapeutic class for acute pain offers an opportunity to mitigate certain risks associated with using an opioid for pain and provides patients with another treatment option,” FDA Center for Drug Evaluation and Research Acting Director Dr. Jacqueline Corrigan-Curay said. “This action and the agency’s designations to expedite the drug’s development and review underscore FDA’s commitment to approving safe and effective alternatives to opioids for pain management.”

A sign for the Food And Drug Administration outside of the agency’s headquarters in White Oak, Maryland. (Sarah Silbiger/Getty Images / Getty Images)

Vertex said that almost 10% of patients initially given opioids to quell acute pain end up using opioids, which can be addictive, for a prolonged period of time.

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Journavx’s wholesale per-tablet acquisition cost will be $15.50, according to the company.

The FDA said that suzetrigine was “contraindicated” for people using “strong CYP3A inhibitors.” It is also advised that patients taking Vertex’s non-opioid medication not eat or drink anything containing grapefruit.

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VRTX VERTEX PHARMACEUTICALS INC. 461.68 +23.28 +5.31%

After the announcement of Journavx’s receipt of FDA approval, Vertex saw gains in its stock price, with its shares posting more than a 5% jump on Friday. Its market capitalization, meanwhile, hovered around $119.81 billion in the afternoon.

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The company said it was also looking into peripheral neuropathic pain applications for the medication.

Vertex has been in business since the late 1980s. Six of the company’s other drugs currently have FDA approval, according to its website.

January 31, 2025
Lay’s recall of classic chips in 2 states classified at highest risk level, FDA warns it could cause ‘death’

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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.

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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.

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Lay’s packaging seen at the grocery store in Las Vegas, United States. (Getty Images / Getty Images)

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The company said no allergic reactions related to this recall have been reported.

January 29, 2025
FDA announces recall of Horizon Organic milk due to spoilage concerns

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A popular brand of organic milk is recalling thousands of cartons of milk due to spoilage concerns, according to the Food and Drug Administration (FDA).

The recall pertains to the 8-ounce size of the Horizon Organic Aseptic Plain Whole Milk. In total, 19,688 cases have been recalled, and the recall was upgraded to Class II on Jan. 17.

The best-by dates of the recalled products are between March 3 and March 7, 2025. The milk was sold in Arizona, California and Nevada.

Affected products were sold under a UPC code of 3663207113 for a 12-pack container, and a single unit UPC code of 3663207127.

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A popular milk brand is recalling thousands of cartons, according to the FDA. (iStock / Getty Images)

On its website, the FDA noted that the milk is potentially susceptible to “premature product spoilage during shelf life.”

According to the FDA’s guidelines, a Class II recall refers to 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.”

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Cartons of Horizon DHA Omega-3 fortified milk at a supermarket in Washington, D.C. (Rich Clement/Bloomberg via Getty Images / Getty Images)

It is not exceedingly uncommon for food to be recalled due to spoilage issues.

Earlier this month, Walmart stores recalled more than 12,000 cartons of Great Value brand chicken broth, citing the reason as “potential for packaging failures that could compromise the sterility of the product, resulting in spoilage.”

Cartons of WhiteWave Foods Co. Horizon Organic milk, a unit of Dean Foods Co., at a supermarket in New York. (Scott Eells/Bloomberg via Getty Images / Getty Images)

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“The health and safety of our customers is always a top priority,” a Walmart spokesperson said in a statement. “As soon as we were made aware of the issue, we took action to remove all impacted product from the select, impacted stores. We are continuing to work with the supplier to investigate.”

FOX Business reached out to Horizon Organic for comment.

FOX Business’ Christine Rouselle contributed to this report.

January 26, 2025