FDA sets risk level on recall of over 2 million MadeGood granola bar cases
The Food and Drug Administration has made updates to a December recall of over 2.4 million cases of MadeGood granola bars, warning consumers of adverse health risks associated with the recall.
Riverside Natural Foods Inc., the Chicago-based parent company of the organic snack manufacturer, voluntarily recalled the products due to the possibility that they were contaminated with metal.
The metal would have been from a small, flat brush bristle used in the manufacturing process, according to MadeGood, which said it received seven complaints that prompted the recall, first announced Dec. 9. The recall was made "out of an abundance of caution and commitment to the well-being of our valued customers," MadeGood said in announcing the decision.
While no injuries have been reported from those who consumed the identified products, the FDA this month rated the recall as a "Class II" level.
See what's being recalled: Check USA TODAY's recall database
Class II recalls are reserved for products that could "cause temporary or medically reversible adverse health consequences" for consumers who are exposed to them. In these situations, the chances for "serious adverse health consequences is remote," according to the FDA.
This is more serious than a Class III recall, in which using a recalled product is not likely to cause adverse health consequences. Class I is the most severe classification for recalls, as it's reserved for products that have a "reasonable probability" to cause serious adverse health consequences or death if used.
In the case of the MadeGood products, the FDA cited the fact that the food "may contain metal pieces" as justification for the classification.
Those products originally recalled include:
Chocolate Chip Granola Bars
Mixed Berry Granola Bars
Strawberry Granola Bars
Cookies & Crème Granola Bars
Chocolate Banana Granola Bars
Chocolate Drizzled Birthday Cake Granola Bars
Chocolate Drizzled Cookie Crumble Granola Bars
Chocolate Drizzled Vanilla Granola Bars
MadeGood granola bar recall by jcannonswim87 on Scribd
The recalled products were produced between January and November 2024 and distributed throughout Canada, the United States and other international markets. An "isolated issue" in the manufacturing process that prompted the recall has already been corrected, MadeGood said in December, adding that it worked with retailers to remove impacted products from store shelves.
"We have addressed the source of the issue and are conducting the voluntary recall with the knowledge of regulatory authorities," MadeGood previously said.
MadeGood is offering refunds to any customer who has a recalled product in their pantry.
Those who have purchased MadeGood granola products are asked to check their package against the recall list. If they have a listed product, they may return it to the store where they bought it for a full refund.
Anyone with questions regarding the recall can call the MadeGood Consumer Hotline at 855-215-5695 between 8 a.m. and 5 p.m. EST or visit the MadeGood website.
Contributing: Mary Walrath-Holdridge, USA TODAY
Eric Lagatta covers breaking and trending news for USA TODAY. Reach him at elagatta@gannett.com
This article originally appeared on USA TODAY: Granola bar recall: FDA sets risk level after MadeGood recall 2M cases
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Alligator Bioscience Receives FDA Endorsement of Mitazalimab Phase 3 Dose for Pancreatic Cancer
LUND, SE / / June 13, 2025 / Alligator Bioscience (Nasdaq Stockholm:ATORX), a clinical-stage biotechnology company developing tumor-directed immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has provided feedback supporting the selection of the 900 µg/kg dose of its CD40 agonist mitazalimab for the planned Phase 3 study in metastatic pancreatic ductal adenocarcinoma (mPDAC). This positive regulatory feedback confirms Alligator's dose selection and represents a key milestone in the late-stage development of mitazalimab. "We are very pleased with the FDA's timely and constructive response. This marks an important step forward as we finalize our Phase 3 program for mitazalimab in one of the most aggressive and underserved cancers. We are now in active partnering dialogues aiming to secure the right partner to take mitazalimab into Phase 3," said Søren Bregenholt, CEO of Alligator Bioscience . For further information, please contact: Søren Bregenholt, CEOE-mail: +46 (0) 46 540 82 00 The information was submitted for publication, through the agency of the contact person set out above, at 8:45 a.m. CEST on 13 June 2025. About Alligator Bioscience Alligator is a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs focused on the CD40 receptor. This validated approach promotes priming of tumor-specific T cells and reversing the immunosuppressive nature of the tumor microenvironment, with significant potential benefits for cancer patients across multiple types of cancer. The Company's lead drug candidate mitazalimab is currently in preparation for Phase 3 development, and has previously presented unprecedented survival data at 24-months follow up in first-line metastatic pancreatic cancer patients in the Phase 2 trial OPTIMIZE-1. Alligator is listed on Nasdaq Stockholm (ATORX) and headquartered in Lund, Sweden. For more information, please visit . Attachments Alligator Bioscience receives FDA endorsement of mitazalimab Phase 3 dose for pancreatic cancer SOURCE: Alligator Bioscience View the original press release on ACCESS Newswire 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


Business Insider
an hour ago
- Business Insider
Moderna receives FDA approval for RSV vaccine
The company states: 'Moderna (MRNA) announced that the FDA has approved mRESVIA, or mRNA-1345, the company's respiratory syncytial virus, RSV, vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 18-59 years of age who are at increased risk for disease. This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older. hile the risk of RSV is well recognized in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable.1 Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease, with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults. This approval was supported by results from Moderna's Phase 3 study, which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions. The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the pivotal Phase 3, placebo-controlled safety and efficacy study. Comparable levels of neutralizing antibodies were observed across both the 18-49 and 50-59 age subgroups, supporting the vaccine's consistent immunogenicity profile in this at-risk, younger adult population. The vaccine was generally well-tolerated, and the most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the U.S. for the 2025-2026 respiratory virus season.'

Business Upturn
2 hours ago
- Business Upturn
Merck Presents Results on Efficacy and Safety of Enpatoran in Systemic Lupus Erythematosus (SLE) at EULAR 2025
Darmstadt, Germany: Cohort B of the Phase 2 study indicates all doses of enpatoran were associated with higher BICLA response rates compared with placebo, though the primary endpoint of BICLA dose-response relationship at Week 24 was not met Data show encouraging efficacy in a large subgroup of SLE patients with active cutaneous manifestations at baseline, including improved response rates in key disease activity measurements There is a substantial unmet treatment need for the estimated 70-80% of SLE patients who experience active cutaneous manifestations, which can profoundly impact quality of life1 Not intended for UK-, US- or Canada-based media Merck, a leading science and technology company, today announced the presentation of detailed results from Cohort B of the global Phase 2 WILLOW study (NCT05162586) evaluating enpatoran, an investigational, oral, novel TLR7/8 inhibitor in systemic lupus erythematosus (SLE). Although it did not meet the primary endpoint of dose-response relationship, when compared to placebo, enpatoran demonstrated improvements in measures of both systemic and cutaneous disease activity in prespecified SLE subpopulations despite standard of care (SoC), including those with active cutaneous manifestations at baseline [(CLASI-A) ≥8], and was overall well tolerated. These findings will be presented in a late-breaking oral presentation at the 2025 European Congress of Rheumatology (EULAR) in Barcelona (Abstract # LB0004). 'Analyses of Cohort B contribute to our understanding of enpatoran's potential to address the critical unmet needs for patients living with lupus, including those experiencing significant skin manifestations. These manifestations are often part of the systemic activity or flare, which can be painful and have a considerable impact on quality of life,' said principal investigator Prof. Eric Morand, from Monash University and Monash Health. 'The improvements observed in key disease measures represent a meaningful advancement in our ongoing investigation of the TLR7/8 inhibition approach for patients insufficiently managed by current therapies.' WILLOW is a global, multicenter, randomized, placebo-controlled Phase 2 study evaluating three doses of oral enpatoran taken twice daily (25 mg, 50 mg and 100 mg) versus placebo plus SoC over 24 weeks. The study features a unique design across two lupus cohorts, including both patients with active SLE and cutaneous lupus erythematosus (CLE). Cohort B of the study was designed to evaluate the dose-response relationship of enpatoran in reducing disease activity, based on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response rate at Week 24 and enrolled SLE patients who had moderate or severe active disease despite SoC. Cohort B showed positive results in secondary and exploratory endpoints and within prespecified patient subpopulations. In patients with active skin disease (CLASI-A ≥8), BICLA response rates were up to 58.6% while placebo response rates were 31.7%, and up to 60.5% of patients receiving enpatoran showed a CLASI-70 response, compared with 26.8% for placebo, at Week 24. In addition, the subgroups of patients with high corticosteroid (prednisone-equivalent ≥10 mg/day) use and those with high interferon gene signature (IFN-GS) at baseline also showed higher and relevant BICLA response rates for enpatoran compared to placebo. As presented earlier this year at LUPUS 2025, Cohort A analyses from the WILLOW study showed clinically meaningful improvement in disease activity in patients with CLE and mild SLE with active lupus rash at Weeks 16 and 24. Overall, for skin-related signs and symptoms, comparable improvements were observed in Cohort B relative to Cohort A, reinforcing the potential efficacy of enpatoran in patients with cutaneous manifestations of lupus erythematosus with or without systemic disease. 'The efficacy and tolerability results from Cohort B, including among those with active skin involvement—a manifestation that affects most lupus patients—are consistent with our observations from Cohort A. The lupus rash is not only a visible symptom but is also closely linked to the underlying systemic activity of lupus,' said Jan Klatt, Head of Development Unit Neurology & Immunology for the Healthcare business of Merck. 'We are set to initiate regulatory discussions with key health authorities to determine the most effective pathway for bringing enpatoran to patients.' Enpatoran was well-tolerated and exhibited a manageable safety profile consistent with previous studies, with no new safety signals identified. Rates of treatment-emergent adverse events (TEAEs) were comparable between all enpatoran arms and placebo, ranging from 60.6% to 64.2%, and the most frequently reported TEAEs were infections and infestations. These results further support the anticipated favorable safety profile of enpatoran. About Enpatoran Enpatoran is a selective Toll-like receptor (TLR)7/8 inhibitor under investigation for the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). By inhibiting TLR7/8 activation, enpatoran may help reduce pro-inflammatory cytokines and autoantibody production, potentially addressing underlying mechanisms of chronic inflammation and disease progression in lupus. With its novel proposed mechanism of action and oral administration, enpatoran has the potential to be a first-in-class treatment for patients across lupus conditions. Enpatoran is currently under clinical investigation and is not approved for any use anywhere in the world. About the Phase 2 WILLOW Clinical Study WILLOW (NCT05162586) is a randomized, double-blind, placebo-controlled Phase 2 proof of concept and dose-finding study designed to evaluate the efficacy and safety of enpatoran in patients with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). The study incorporates a basket design, including two cohorts – Cohort A including patients with CLE or SLE with active lupus rash and Cohort B including patients with active SLE. The WILLOW study aims to advance the understanding of enpatoran's therapeutic potential and to help address significant unmet needs in lupus treatment. About Lupus Erythematosus Lupus erythematosus is a chronic autoimmune disease that can affect various parts of the body, including the skin, joints, kidneys, and other organs. It occurs when the immune system mistakenly attacks healthy tissues, leading to inflammation, pain, and potential organ damage. There are multiple types of lupus, with systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE) being two primary forms. Symptoms can range from mild to life-threatening, often including fatigue, joint pain, rashes, and organ involvement. Lupus disproportionately impacts women and people of color, and despite available treatments, many patients experience unmet needs due to limited efficacy or side effects. Merck in Neurology and Immunology Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company's current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck's commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG). About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck generated sales of € 21.2 billion in 65 countries. The company holds the global rights to the name and trademark 'Merck' internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to to register online, change your selection or discontinue this service. 1 Cojocaru M, Cojocaru IM, Silosi I, Vrabie CD. Manifestations of systemic lupus erythematosus. Maedica (Bucur). 2011 Oct;6(4):330-6. PMID: 22879850; PMCID: PMC3391953. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash