All articles tagged with #fda
An FDA advisory panel recommended approval for Grail’s Galleri multi-cancer blood test, despite a large UK trial failing to show reduced late-stage diagnoses. Critics warn that Medicare coverage mandates could impose billions in costs without proven mortality benefits, while proponents highlight the test’s ability to detect cancers currently missed by standard screenings.
PepsiCo is voluntarily recalling 122,021 cases of 28-ounce Gatorade bottles across 37 states, including New York and New Jersey, due to undeclared food dyes. The FDA classified the action as a Class II recall on Oct. 2, 2026, indicating a remote risk of serious health consequences. Affected flavors include Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero, which may contain unlisted Yellow No. 5 or Yellow No. 6. Consumers are advised to check lot numbers and return products for refunds.
A Chilean supplier has expanded a frozen berry recall to 56 states and Puerto Rico due to potential E. coli contamination. Affected products include Great Value and Trader Joe's organic berry blends. Consumers should discard or return these items for a refund.
The FDA has expanded a frozen berry recall to 56 states and Puerto Rico due to potential E. coli contamination. Affected products include Great Value organic blueberries and berry blends at Walmart, and Trader Joe's organic mixed berry blends. Consumers should discard or return these items for a refund.
The FDA has expanded a frozen berry recall to 56 states and Puerto Rico due to potential E. coli contamination. Affected products include Great Value organic blueberries and berry blends at Walmart, and Trader Joe's organic mixed berry blends. Consumers should discard or return these items for a refund.
The FDA expanded a frozen berry recall to include Great Value and Trader Joe's products in 56 states, citing potential E. coli contamination. Consumers should discard affected lots or return them for a refund.
The FDA has confirmed the presence of the cyclospora parasite at a Mexican farm linked to a massive U.S. foodborne illness outbreak, closing its investigation. The outbreak sickened nearly 13,000 people across 21 states, resulting in 570 hospitalizations and two deaths. While the agency found the parasite in wastewater and drainage areas, it remains unclear how the contamination reached the lettuce, and Taylor Farms has since removed the implicated grower from its supply chain.
The recall for frozen berries linked to a multistate E. coli outbreak has expanded to include products sold in Ohio, Kentucky, and Indiana. This follows earlier recalls of GreenWise berries at Publix and Great Value organic triple berry blends at Walmart. The FDA is treating the expansion as a precautionary measure based on traceback data, despite no illnesses yet being tied to the newly affected items. Consumers are advised to discard or return the products.
Stewart's Shops is voluntarily recalling half-gallon cartons of Heavenly Medley and Vanilla-Chocolate-Strawberry ice cream across New York, Vermont, and New Hampshire. The recall, coordinated with the FDA, follows a consumer report of a metal object in the product. No illnesses have been reported, and customers are advised to return the items for a full refund.
The FDA concluded its investigation into the largest US cyclosporiasis outbreak, confirming the parasite was present at the Taylor Farms facility in Guanajuato, Mexico. Inspectors found cyclospora in a wastewater tank and a drainage ditch, though the agency could not determine how the lettuce became contaminated. The outbreak sickened nearly 13,000 people across 21 states, resulting in 570 hospitalizations and two deaths. Taylor Farms blamed an independent grower no longer in its supplier program, while Mexico’s food safety authority previously reported no contamination at the site.
The FDA has closed its investigation into the largest U.S. cyclosporiasis outbreak, confirming the parasite was present at Taylor Farms' Mexican processing site and in the fields where the implicated lettuce was grown. However, the agency stated it could not determine how the contamination occurred. The outbreak sickened over 12,000 people across 21 states and resulted in two deaths. While the CDC previously declared the outbreak over as cases declined, this FDA finding provides environmental confirmation of the parasite's presence but leaves the specific transmission mechanism unresolved.
At ARDD 2026, senior FDA officials confirmed that aging and longevity will be included in the agency's upcoming focus areas of regulatory science. The panel outlined a phased approach to approving anti-aging therapies, starting with hard endpoints like mortality and comorbidity prevention before moving to validated surrogate measures. They emphasized the need for pre-competitive consortia to develop shared biomarkers and warned against repurposing existing drugs without clear evidence of broader benefits.
Merck has ceased manufacturing and marketing Recarbrio in the US, citing portfolio reviews rather than safety issues. The drug, a combination of imipenem-cilastatin and relebactam, was approved in 2019 for multidrug-resistant infections, including those caused by Klebsiella pneumoniae carbapenemase. While experts note alternative treatments exist for some pathogens, the withdrawal leaves a gap for difficult-to-treat Pseudomonas aeruginosa cases. Critics argue this move highlights the economic unsustainability of new antibiotics, which are used sparingly due to stewardship guidelines, raising concerns about future pediatric access and the need for legislative support like the PASTEUR Act.
Merck has discontinued Recarbrio, a critical three-drug antibiotic combination, from the U.S. market. The drug, approved seven years ago, was designated by the FDA as a treatment of last resort to combat antibiotic resistance. Merck did not provide a reason for the withdrawal, raising concerns about corporate commitment to public health priorities.
The U.S. Department of Justice unsealed an indictment against two Indian nationals, Swapnadip Roy and Vicky Ramancha, for allegedly smuggling counterfeit Ozempic from China to U.S. distributors. The scheme, which ran from July 2023 to April 2024, continued even after the FDA seized fake units and issued public warnings. Roy was extradited from Italy to face charges in Florida, while Ramancha remains at large. If convicted, both face up to 71 years in prison.