Popular hot sauce recalled in 10 states due to possible ‘life-threatening' allergen
A popular hot sauce brand is recalling select products because they may contain an unlisted ingredient that could pose life-threatening risks to some consumers.
The U.S. Food and Drug Administration (FDA) announced last Thursday that T.W. Garner Food Company is recalling its Texas Pete Habanero Buffalo Sauce because it may contain Sriracha Sauce, which includes sulfites — a known allergen not disclosed on the product label. Sulfites can trigger severe or potentially fatal allergic reactions in sensitive individuals.
In addition, the company is recalling its Texas Pete Sweet CHAbanero Sauce due to an omission of Aged Peppers in the ingredients list.
The recall includes both the 12-ounce and the two-ounce bottles of the habanero buffalo sauce with 'best-by' dates of November 7, 2025, and December 5, 2025.
For the Sweet CHAbanero Sauce, the two-ounce bottles with MFR codes BB 090427M and BB 082627M, as well as the 20 fluid-ounce and half-gallon containers, were recalled.
The hot sauce bottles were distributed between February 5 and March 26, according to the FDA's report. They were shipped to distribution centers and other stores in California, Colorado, Connecticut, Illinois, Massachusetts, North Carolina, New Jersey, Ohio, Virginia, and Vermont.
There have currently been no reported illnesses as a result of the labeling error. Customers who have purchased the recalled bottles of hot sauce are urged to either dispose of them or return them in exchange for a full refund.
The news comes just a few days after a popular brand of sausages was recalled due to a potential plastic contamination.
Johnsonville, LLC is recalling approximately 22,672 pounds of its cheddar bratwurst product, according to an announcement shared by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) on Saturday.
The recall was issued because the sausages may have been contaminated 'with foreign material, specifically hard plastic.'
Each of the tray packages contains five pieces of 'Johnsonville BRATS CHEDDAR Bratwurst' and the package code B9FOD. The recalled product has the establishment number 'Est. 1647' on the front of the label. They were first produced on February 5, 2025.
The affected sausages were sent to various retailers in 10 states: Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, Ohio, Tennessee, Virginia, and Wisconsin.
The recall was initiated after Johnsonville, LLC received complaints from two different customers reporting hard plastic found in their bratwurst. At the time of writing, there have been no reports of injuries due to the consumption of the sausage.
FSIS is urging consumers not to eat these products and to throw them away immediately. Consumers can also return the recalled product to the store they bought it from.
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Medera and Novoheart Presented Breakthroughs in Human mini-Heart Platforms and Gene Therapy at ISSCR 2025
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For more information, please visit About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives. For more information, please visit Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as "estimate," "plan," "project," "forecast," "intend," "expect," "anticipate," "believe," "seek," "strategy," "future," "opportunity," "may," "target," "should," "will," "would," "will be," "will continue," "will likely result," "preliminary," or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC's, Medera's, or their respective management teams' expectations concerning the outlook for their or Medera's business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC's public shareholders, growth prospects and outlook of Medera' operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera's projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger ("Transaction"). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC's securities; (ii) the risk that the Transaction may not be completed by KVAC's business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera's business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC's securities or to meet listing requirements and maintain the listing of Medera's securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera's ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera's business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera's limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the "Risk Factors" section of KVAC's Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 29, 2024, the risks to be described in the registration statement, which will include a preliminary proxy statement/prospectus, and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC's public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera filed a registration statement with the SEC, which includes a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC's ordinary shares in connection with KVAC's solicitation of proxies for the vote by KVAC's shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the "Proxy Statement"). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at In addition, the documents filed by KVAC may be obtained free of charge from KVAC's website at or by directing a request to info@ The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC's directors and executive officers, please refer to KVAC's annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at and registration statement, Proxy Statement and other relevant materials filed with the SEC in connection with the Transaction when they become available. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC's shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts: Keen Vision Acquisition CorporationAlex DavidkhanianChief Financial OfficerEmail: MederaInvestor RelationsStephanie CarringtonICR 277-1282 Media RelationsSean LeousICR 866-4012
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This data was shared at the prestigious ISSCR 2025 Annual Meeting in Hong Kong by Francisco Silva, Vice President of Research and Development. The U.S. Food and Drug Administration ('FDA') is requiring at least a greater than 30% improvement in function in the Oswestry Disability Index ('ODI') and a greater than 30% reduction in pain on the Visual Analog Scale ('VAS') in determining whether the clinical trial will be allowed to proceed and ultimately gain Biologics License Application (BLA) approval. Key Highlights: Patient Numbers Growing: The number of subjects evaluated has increased from 15 to 36 since the Company's last press release — an important milestone toward full Phase 2 enrollment (up to 99 subjects). Compelling Clinical Signals: Over 74% of subjects showed >50% improvement in function (ODI) by 52 weeks; Over 72% of subjects reported >50% reduction in pain (VAS) by 52 weeks; Combined >50% improvement in both ODI and VAS measures was achieved by a meaningful portion of subjects across all timepoints. Excellent Safety Profile: No serious adverse events (SAEs) or dose-limiting toxicities reported between 26 and 104 weeks at the target dose (40 million cells). Strengthening Data: Each new data analysis has outperformed prior releases, highlighting an upward trend in efficacy markers. The following is a detailed breakdown of the subjects that had greater than 50% improvement in function, as measured by ODI, greater than 50% decrease in pain, as measured by VAS, and greater than 50% improvement in both ODI and VAS: Week Percentage of Subjects With >50% Average Improvement in ODI Percentage of Subjects With >50% Average Improvement in VAS Number of Subjects With >50% Average Improvement in Both ODI and VAS Baseline 0.00 % 0.00 % 0/36 12 67.57 % 73.82 % 5/25 26 74.04 % 76.94 % 6/15 52 74.63 % 72.35 % 8/10 104 75.13 % 68.54 % 2/4 'With every new analysis, our confidence grows that BRTX-100 is positioned to meet and potentially exceed the FDA's functional and pain reduction thresholds,' said Lance Alstodt, Chief Executive Officer of BioRestorative. 'We are excited by the trajectory of this material milestone and its potential to address a massive unmet need in chronic lower back pain — one of the largest global healthcare burdens. 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You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K, filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements. CONTACT: Stephen KilmerInvestor RelationsDirect: (646) 274-3580 Email: skilmer@
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Many people within the health and science world (and beyond) are concerned by this move, including Elisabeth Marnik, a scientist and science communicator based in Maine, who is particularly worried about the shift to AI after fake citations made their way into a Make America Healthy Again report just a few weeks ago, likely due to unsystematic AI use. There are other concerns, too. 'The FDA's move to explore AI for accelerating drug and device approvals and for food ingredient oversight marks a critical inflection point in regulatory innovation, but it also introduces a series of legal, ethical and structural tensions that can't be glossed over,' Stacey B. Lee, a professor of law and ethics at Johns Hopkins Carey Business School and Bloomberg School of Public Health, told HuffPost via email. The Department of Health and Human Services didn't immediately respond to HuffPost's request for comment. Below, experts share more thoughts on the FDA's AI implementation. 'It's a bit disorienting because it feels like they are doing the thing that they are also criticizing in that they're on this big agenda of almost re-litigating all processes established by our public health agencies to ensure 'safety and efficacy' and yet they're also wanting to expedite things,' said Jessica Malaty Rivera, an infectious disease epidemiologist. Moving quickly through processes while guaranteeing 'safety and efficacy' generally don't go hand-in-hand. 'That feels like you can't have both things at the same time,' she added. Health and Human Services Secretary Robert F. Kennedy Jr. has said he wants to put many vaccines through longer trials, and while the FDA's AI use hasn't been pegged for vaccine trials, 'they are still saying that they want to shorten review times and speed up the delivery of treatments to people who need them,' Malaty Rivera said. Kennedy also repeatedly promises 'radical transparency' in health care, yet AI threatens that transparency, experts say. 'I haven't been able to find great, transparent information about exactly where and how they're using AI. They talk about using it for review, but in what way?' said Marnik. 'The law doesn't prohibit innovation, but it does demand accountability,' said Lee. 'Any AI implementation must be subject to clear statutory authority, rigorous oversight and published methodologies to preserve public trust,' she added. This goes back to transparency. 'The core concern is opacity. AI tools, especially proprietary or black-box models, can obscure how decisions are made. If a drug is greenlit or a food ingredient is flagged based on an algorithm that the public can't scrutinize, it erodes due process and patient safety,' Lee said. 'This move also raises critical structural questions: If an AI system contributes to a faulty approval or missed red flag, who's accountable? The software developer? The FDA staffer who relied on the tool?' There is currently a large liability gap, she noted — 'and the regulatory framework hasn't caught up.' When it comes to using AI to look at the 'concerning' ingredients in food in the U.S., Malaty Rivera has concerns. 'MAHA and Marty Makary, in particular, continue to spread misinformation about the safety of food,' she said. 'They continue to malign things that are not harmful to people, like seed oils, they continue to misrepresent even the ingredients of baby formula.' Many of the words used to vilify certain foods and certain ingredients are wellness marketing gimmicks, 'things like non-GMO and organic and pushing things like beef tallow and raw milk,' she added. She also voiced concerns about the data and language that could be used to inform the AI systems when it comes to food regulations. 'I don't trust the people that are in charge of these decisions to make evidence-based decisions on food ingredients. I really don't,' she said. 'We also need to consider bias in training data. If the AI is trained on historically biased data — say, clinical trials that underrepresent women or communities of color, we risk automating disparities in approvals or warnings,' Lee said. Research shows that AI itself is biased and even is known to prop up racist stereotypes. More, how would AI handle the so-called 'DEI-related' words that are currently banned from science research by the Trump administration? 'I don't even know if, because of all these banned words, if applications that even have words that have been considered banned would even pass through these AI models designed by people creating the word bans,' added Malaty Rivera, who added that she wants to know how equity and unbiased review will be ensured in the AI process. 'I would love to see the methodology. I would love to see the ways in which it's not going to cause further harm,' she said. Many people are leery of AI, and for good reason. It's taking jobs, has plagiarism issues, is linked to privacy concerns and, as mentioned above, it's known to be biased. But, when used properly, there are pros to AI both at the FDA and in everyday life. 'In food regulation, especially, this could be a breakthrough. AI can scan molecular structures and evaluate safety profiles at a scale no human team could match,' said Lee. 'But the system has to be designed to prioritize health, not convenience,' 'I do think eventually AI will be a useful tool in helping streamline things and potentially even helping analyze big data sets,' Marnik said, 'but I think that there's a lot of steps we have to go through to make sure that's actually happening correctly before it's used on such a federal level. Malaty Rivera noted that AI isn't going anywhere and while it could be useful to review thousands of pages of information, it would be a mistake to completely remove humans from the process. No matter what AI is used for at the FDA, processes must be in place to ensure fairness and accuracy, experts say. 'If this is going to be what you want to eventually use, there should be essentially a scientific process to establish that the system is actually working as well as you think it's working and is actually working as well as a human review process,' Marnik said, adding that without systems (and people) to make sure AI is functioning properly, there can be major issues. Lee noted informed decisions need to be reviewed, explained and equitable for patients, researchers and policy makers. 'AI in health care is not just a tech issue; it's a trust issue,' Lee said. Otherwise, more people could be led to distrust the medical system. And levels of distrust are already high, with roughly two-thirds of Americans expressing a lack of faith in the medical establishment. 'The FDA's AI pilot comes at a moment when public trust in health institutions is already fragile. Getting this right means building the right guardrails now, not after the first high-profile failure,' Lee said. 'That includes independent audits, transparent reporting, human oversight and clear legal responsibility.' Malaty Rivera said if she believed in the scientific rigor and integrity of the people at the helm of the FDA, the use of AI in health and science would be one thing. 'But I don't. And so I don't trust these decision makers to be designing and/or navigating these tools,' she said. Malaty Rivera also added that the people appointed under the MAHA regime have an agenda that isn't evidence-based science. 'The agenda is this alternative, contrarian version of health and wellness that is often spreading a lot of harmful misinformation,' she said. Marnik added that she doesn't think AI is currently able to do rigorous scientific reviews or find limitations associated with scientific data, which is crucial for the FDA when it comes to medical approvals. 'AI is only as good as the prompts and the directions that you give it, and what it's been trained on,' Marnik said. 'So, ultimately, I think this is too soon, and I would like to know more about exactly how they plan to use it.' RFK Jr. Went Swimming In Sewage Water — Health Experts Beg You Not To Do That. If RFK Jr. Actually Gave An F About Health, Here's What He'd Focus On Instead RFK Jr.'s Stunning Claim About Black People And Vaccines Sparks Concern From Medical Experts
