• Infant formula maker ByHeart has recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack sticks due to an outbreak of infantile botulism linked to the company’s products. ByHeart initiated the recall of two batches of formula on November 8, 2025, after it was notified of approximately 13 reported cases of botulism in infants that had consumed its products throughout the U.S. The company expanded the recall three days later after an additional 10 cases were reported.
  • California officials reported that a sample taken from an open can of ByHeart formula contained Clostridium botulinum, which leads to botulism infection. According to ByHeart, no previously unopened product has tested positive for the bacteria. In addition to recalling product, the company is conducting testing of every batch of formula through a third-party laboratory and providing FDA and the California Department of Public Health access to its facilities and unopened product for testing.  
  • The families of at least two babies who were treated for botulism have sued ByHeart, alleging the company negligently sold defective formula that they purchased because they viewed it “as a natural, healthier alternative to traditional baby formulas.” The families are seeking payment for medical bills, emotional distress, and other harm.  
  • Illnesses linked to ByHeart formula began between August 9 and November 11 and were reported in 13 states. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak.
  • Keller and Heckman will continue to monitor and report on this and other foodborne illness outbreaks.
  • On July 9, 2025, FDA Commissioner Marty Makary published a letter encouraging manufacturers of infant formula, baby food, and foods intended for children to improve their product recall communications. The letter urges industry leaders to adopt FDA’s “radical transparency” efforts to help protect what Commissioner Makary calls “our most vulnerable consumers—our children.” Specifically, Commissioner Makary calls on industry leaders to “consider expanded use of public notification as appropriate to ensure that consumers have access to the most timely and comprehensive information.”
  • FDA outlines both short-term and long-term goals within the letter. In the short term, FDA plans to create a “centralized, consumer-focused webpage for streamlined access to recall information” for infant formula, baby food, and foods intended for children. FDA also mentions that the Agency hopes to improve its own communications about recalls “by leveraging focus group research and other stakeholder feedback on risk communication strategies.” In the long term, FDA aims to improve recall process efficiency “by redesigning and digitizing key recall documentation to support automated data extraction and AI-assisted analysis,” as well as modernize the digital platform where manufacturers submit recall information.
  • The letter is an extension of a March 18, 2025, FDA announcement of its new initiative known as “Operation Stork Speed.” This initiative seeks to improve product recall communications with consumers, and encourage companies to work alongside FDA to “[increase] transparency” and create “clearer labeling” on their products. Before transitioning to the current administration, FDA had also released a strategy in January 2025 outlining goals to improve safety requirements and “resiliency” in the infant formula market by addressing vulnerabilities in production and regulatory oversight.
  • Keller and Heckman will continue to report on FDA announcements and updates that impact the infant formula and children’s food space.
  • On October 11, 2024, Costco issued a recall for nearly 80,000 pounds of its Kirkland Signature butter due to a labeling oversight.  Milk, classified as one of the nine major allergens that the U.S. Food and Drug Administration (FDA) requires to be declared on product packaging, was not included on the ingredient list.  The recall included 46,800 pounds of Kirkland Signature Unsalted Sweet Cream Butter and 32,400 pounds of  Kirkland Signature Salted Sweet Cream Butter.
  • The Food Allergen Labeling and Consumer Protection Act of 20024 (FALCPA) identified eight foods as major allergens: milk, eggs, fish, crustacean, shellfish, tree nuts, peanuts, wheat, and soybeans.  The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 added sesame as the ninth major food allergen.  These laws require all food labels to identify the source names of all major food allergens.
  • The recall has gained attention across social media platforms with consumers commenting that it should be obvious that butter contains milk.  However, the purpose of allergen labeling is to help consumers with allergies avoid consuming products with hidden allergens. For those with Milk allergies, consuming products with undeclared milk ingredients can lead to serious health risks, including allergic reactions that may require medical attention. 
  • Consequently, on November 7, 2024, FDA classified the recall as a Class II recall, indicating that the product may cause temporary or medically reversible adverse health consequences.
  • Social media commentary aside, adhering to allergen labeling requirements is critical in ensuring consumer and product safety.
  • Keller and Heckman will continue to monitor and report any significant recalls.
  • On February 5, 2024, Rizo-Lopez Foods, Inc. voluntarily recalled its dairy products due to potential Listeria monocytogenes contamination. The recall stems from an outbreak including cases dating back to 2014 and CDC inspections in 2017 and 2021. In response to a sample that tested positive for Listeria in January 2024, Rizo-Lopez recalled one batch of cotija cheese. CDC and FDA reopened the investigation when an analysis showed that the same strain in that sample caused illness in an outbreak that was reported in December 2023.
  • The recall includes cheese, yogurt, and sour cream sold under multiple brand names nationwide. In addition to Rizo-Lopez brands, the products were used in dressings, sauces, kits, and more under other brands, including Bright Farms, Costco, H-E-B, and Trader Joe’s, among others. The full list of affected products is available on FDA’s webpage covering the outbreak.
  • As of February 12, there have been 26 reported illnesses, 23 hospitalizations, and two deaths across 11 states. Listeria is a bacteria species found in moist environments that can survive and grow even under refrigeration. People infected with Listeria may develop symptoms including fever, muscle aches, nausea, vomiting, and diarrhea. More severe cases may include headache, stiff neck, confusion, loss of balance, and convulsions. Symptoms may develop in anywhere from a few hours to three months after eating contaminated food. Listeria can be particularly harmful to people with weakened immune systems, people over 65, and pregnant women and babies.
  • Although the investigation is ongoing, FDA’s inspection of the Rizo-Lopez facilities turned up an environmental sample that tested positive for the same strain of Listeria that is causing illness in the outbreak.
  • Keller and Heckman will continue to monitor this outbreak and report on any updates.
  • Following a previous recall of its Chewy granola products in December, Quaker Oats has broadened its recall to its granola bars, snacks, and some varieties of its popular Cap’n Crunch cereal products sold nationwide due to possible Salmonella contamination.
  • The U.S. Food and Drug Administration (FDA) has provided a list of the affected products, which now include the following:  Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple, Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple and Splendid Strawberry Variety Pack, Quaker Chewy Granola Bars Yogurt Strawberry Flavor, Cap’n Crunch Treats Crunch Berries Cereal Bar, Quaker Chewy Granola Breakfast Cereal Strawberry, Cap’n Crunch Cinnamon Crunch Cereal, and Cap’n Crunch OOPS! All Berries Instant Oatmeal.
  • Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.
  • The listed products were sold throughout the US, Puerto Rico, Guam, and Saipan.  Consumers can scan the SmartLabel QR code on the product package to determine whether it has been recalled.
  • Keller and Heckman will continue to monitor and relay any updates regarding food safety.
  • The U.S. Food and Drug Administration (FDA) has provided an update regarding the cinnamon applesauce pouches that have been recalled.  FDA’s investigation began on November 9, 2023, when WanaBana USA voluntarily recalled all lots of WanaBana Apple Cinnamon Fruit Puree pouches, Schnucks-brand cinnamon flavored applesauce pouches, and Weis-brand cinnamon applesauce pouches due to reports of elevated levels of lead.
  •  As of January 8, 2024, FDA has received 87 confirmed complaints/reports of adverse events potentially linked to the recalled product.
  • CDC’s National Center for Environmental Health is currently conducting case finding efforts in collaboration with state and local health departments.  As of January 5, 2023, CDC has received reports of 86 confirmed cases, 209 probable cases, and 26 suspected cases, totaling 321 cases from 38 different states through their reporting structure.
  • FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.  Because of the products’ long shelf life, cases are still being reported.
  • Keller and Heckman will continue to monitor and relay any developments in the investigation.
  • The U.S. Food and Drug Administration (FDA) has announced the recall of various stone fruit linked to an outbreak of Listeria monocytogenes.  Specifically, HMC Farms is voluntarily recalling conventional (non-organic) peaches, plums, and nectarines sold in retail stores from May 1, 2022 through November 15, 2022 and from May 1, 2023 through November 15, 2023.  The recalled fruit was sold at retail stores such as Publix, Walmart, Sam’s Club, Sprouts Farmers Market, and Albertsons nationwide in bags or as individual pieces of fruit with PLU stickers, under multiple brand names.
  • Additionally, the recalled fruit was sold to other manufacturers who may have frozen and/or relabeled the recalled fruit for resale under another brand.  The recalled fruit is past expiration and no longer available for sale in retail stores, but could have been frozen by consumers.
  • Symptoms of Listeriosis (Listeria infection) usually start within two weeks after eating food contaminated with Listeria, but may start as early as the same day or as late as ten weeks after.  Mild symptoms may include a fever, muscle aches, nausea, tiredness, and vomiting.  If the more severe form of listeriosis develops, symptoms may include headache, stiff neck, confusion, loss of balance, and convulsions.
  • FDA’s investigation is ongoing to determine the source of contamination and if additional products are linked to illness.
  • FDA and the Center for Disease Control and Prevention (CDC) are also investigating an ongoing Salmonella outbreak linked with recalled cantaloupe products that has caused at least 99 illnesses and two deaths in 32 states.
  • Keller and Heckman will continue to monitor and report significant food safety developments.
  • A salmonella outbreak traced to cantaloupe imported from Mexico has spread through several U.S. states and Canada. As of November 17, 2023, at least 43 people in the U.S. and eight people in Canada had been infected with Salmonella linked to the same cantaloupes. At least 17 of those people required hospitalization.
  • On November 15, 2023, Sofia Produce, LLC issued a recall of all fresh cantaloupes it distributed in packages labeled with the “Malichita” brand between October 16 and 23, 2023. The cantaloupes were distributed directly to Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Michigan, Wisconsin, Texas, Florida, and Canada, and may have reached consumers through retail outlets outside of those areas.
  • The outbreak also includes Vinyard brand pre-cut cantaloupes and ALDI brand whole and pre-cut cantaloupes. Sofia Produce is contacting each of its buyers to advise them of the recall. Consumers should check to see if they have recalled products, which should not be consumed. If consumers are unsure whether they have purchased a recalled product, they are advised to contact their retailer.
  • Keller and Heckman will continue to monitor and report on food recalls in the U.S.
  • Kraft Heinz is recalling about 83,000 cases of its individually wrapped Kraft Singles American cheese, as they might be considered a choking hazard.  The company stated that a “temporary issue” with one of its wrapping machines means that a “thin strip of the individual film may remain on the slice after the wrapper has been removed.”  If not removed, it could be “unpleasant and potentially cause gagging or choking hazard.”
  • The recall comes after several customer complaints of finding the piece of plastic on the cheese.  No injuries or health issues have been reported and the faulty machine has since been fixed.
  • The issue affects two types of packing, including 16-ounce “Kraft Singles American Pasteurized Prepared Cheese Product” with a “Best When Used By” date between January 10, 2024, and January 27, 2024.  Individual packages in this recall contain an “S” and “72” in the manufacturing code on the packaging.  Also affected are the 3-pound multipacks of “Kraft Singles American Pasteurized Prepared Cheese Product” with a UPC code of 0-2100060491-3 and a “Best When Used By” of January 9, 2024 and January 16, 2024.
  • The recall comes after Kraft announced earlier this year that it was changing the packaging on its individually wrapped cheese to make them easier to open. 
  • On August 9, Real Kosher Ice Cream voluntarily recalled soft serve on the go ice cream and sorbet cups due to potential contamination with Listeria monocytogenes, an organism which can cause serious infections in young children, the elderly, and individuals with weakened immune system. The ice cream products were distributed in over 19 states nationwide through canteens, grocery and convenience stores.
  • To date, two cases of illness have been reported in this outbreak in New York and Pennsylvania. Both individuals were hospitalized but no deaths have been reported to date. On August 23, FDA confirmed that Listeria matching the sick people’s samples was found in an unopened sample of the implicated ice cream during testing by the Pennsylvania Department of Agriculture. In addition, the New York Department of Agriculture and Markets found the outbreak strain of Listeria in five finished samples of “Soft Serve On the Go” ice cream cups collected from the company’s manufacturing facility.
  • Keller and Heckman will continue to monitor and report on food recalls in the US.