Search recall

  • FDA has released the results of sampling conducted on domestic and imported honey in 2025 for economically motivated adulteration. The Agency found that 4% of the 102 honey samples tested were adulterated with undeclared added sweeteners.  
  • According to FDA, “honey” commonly refers to “the thick, sweet, syrupy substance that bees make from the nectar of plants or their secretions and store in honeycombs.” Honey becomes adulterated through economic motivation when less expensive sweeteners, such as syrups derived from sugarcane, corn, rice, or sugar beets, are added to honey and not declared.
  • In fiscal year 2025, FDA collected and tested 54 domestic and 48 imported honey samples from either bulk shipments or retail containers labeled as “honey.” The Agency used Stable Carbon Isotope Ratio Analysis to analyze each sample and its protein extract. Of the samples collected, 2 domestic and 2 imported samples—4% of the total—were violative. This percentage is slightly lower than in previous sampling assignments conducted in 2021-22 and 2022-23.
  • For the violative samples, FDA worked with the domestic firms on corrective actions, including voluntary recall, and placed the importing firms on Import Alert 99-47, “Detention Without Physical Examination of Human Food Products That Appear to be Adulterated for Economic Gain.”
  • FDA noted that the results of the sampling show that honey is “susceptible to economically motivated adulteration.” Although adding undeclared sweeteners to honey does not pose a public health risk, FDA reiterated the importance of truthful, non-deceptive food labels. Honey with added sweeteners should be labeled as a “blend” with all components declared in an ingredient statement.
  • Keller and Heckman will continue to report on similar FDA sampling activities.
  • FDA’s Office of Coordinated Outbreak Response, Evaluation, & Emergency Preparedness (CORE+EP) has released its 2024 Annual Report, offering stakeholders a comprehensive look at the agency’s foodborne outbreak and adverse event investigations from 2024.
  • In 2024, CORE+EP evaluated 72 incidents, initiated 26 response efforts, and issued 10 public health advisories. The report highlights several significant investigations, including a large E. coli outbreak linked to carrots, a long‑running cheese‑associated outbreak dating back to 2018, and a novel series of adverse events tied to certain chocolate bars, cones, and gummies.
  • Of the 26 responses initiated, produce remained the dominant source of identified outbreaks, accounting for 55% of all responses with a confirmed product link; primarily tied to romaine lettuce, spinach, cucumbers, jalapeno peppers, onions, carrots, sprouts, basil, and parsley. Multi‑ingredient foods represented another 20% of identified sources, including shrimp salad, frozen shakes, bagged salad mixes, and the chocolate bars, cones, and gummies associated with a novel adverse event series. Meanwhile, dairy products accounted for 10%, while fruits, shell eggs, and nuts each comprised 5%. The agency issued ten public health advisories, nine tied to multistate outbreaks and one related an event series, resulting in a significant number of regulatory actions including multiple voluntary recalls, expanded recall announcements, two warning letters, a country‑wide import alert for Salmonella‑contaminated cucumbers, and a consent decree of permanent injunction for Listeria‑contaminated queso fresco and cotija cheese products.
  • The report also highlights progress in FDA’s implementation of the Food Traceability Rule (FTR) under FSMA Section 204(d), signaling an important shift in how outbreak investigations will be conducted moving forward.
  • Keller and Heckman will continue to monitor federal responses to foodborne outbreaks and related regulatory developments.
  • “STOP Foodborne Illness,” a non-profit organization, petitioned FDA last month to adopt a policy of publicly disclosing the names of all companies associated with foodborne illness outbreaks, whether or not there is a related recall.
  • FDA has long viewed certain business relationships, such as raw material supplier lists, finished product customer lists, and trace-back information as confidential commercial information (CCI), protected from public disclosure. The petition argues that FDA incorrectly classifies company names as CCI under the Trade Secrets Act. The Trade Secrets Act permits disclosure of CCI when “provided by law” (18 USC 1905). FDA considers this requirement met in a recall situation based on 21 CFR 20.91, which permits the use of non-public information to the extent necessary to effectuate an enforcement action.
  • The petition requests that FDA change its interpretation of CCI to exclude company names “through an agency statement or memorandum.” In the alternative, the petition requests that the agency either:  
    • Disclose company names in recall situations by relying on its authority to “protect the public by ensuring that foods are safe” (21 USC 393(b)(2)(A)).
    • Revise the language in 21 CFR 20.91 to permit the disclosure of company names in all outbreak situations. The petition disfavors this latter approach because it would require rulemaking.
  • On February 26, 2026, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) announced that the multistate outbreak of infant botulism (C. botulinum) has ended, with no new illnesses reported since December 2025.
  • As we previously reported, the outbreak was linked to ByHeart infant formula products.  The company initiated recalls after illnesses were linked to its formula between August 9 and November 11 and were reported in 13 states.  As of February 26, 2026, the investigation includes 28 cases of confirmed infant botulism and 20 cases of probable infant botulism.  All ByHeart infant formula products have been recalled.
  • Another infant formula recall lead to a global shortage in 2022, which ignited a larger discussion on infant formula market concentration (see FTC and NASEM reports). 
  • Keller and Heckman will continue to monitor developments regarding infant formula.
  • On October 1, 2025, the US federal government shut down after lawmakers failed to pass a new appropriations bill.  Federal agencies and departments have certain operational procedures during shutdowns, and some government services will be temporarily suspended, as an estimated 41% of the federal workforce will be put on unpaid leave. 
  • The US Department of Health and Human Services (HHS) recently issued its FY 2026 Contingency Staffing Plan for Operations in the Absence of Enacted Annual Appropriations.  The plan states that it expects more than 32,000 of its nearly 80,000 workers to be furloughed during the shutdown.  As a result, certain aspects of U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) operations will be affected.  The plan indicates that FDA will continue with its core functions to “handle and respond to emergencies” and that “FDA activities related to imminent threats safety of human life” will continue.  These include responding to public health emergencies and foodborne illness outbreaks; review of import entries; conducting for cause and certain surveillance inspections of regulated facilities; and criminal enforcement work.
  • Although FDA will continue to respond to foodborne illness outbreaks, FDA’s Coordinated Outbreak Response and Evaluation (CORE) Response Teams stated that these outbreaks will no longer be reported: “Due to the absence of either a fiscal year 2026 appropriation or a Continuing Resolution, only certain government activities will continue.  While FDA will continue to conduct foodborne outbreak surveillance and response activities, the CORE Investigation Table will not be updated weekly during this time.  FDA will continue to issue public warnings if there is actionable information to protect consumers from foodborne illness.”  FDA did not note whether it will continue to post recall notices.
  • Regulated entities should expect delays in routine inspections and submissions.  This may affect the review timeline for submitted GRAS notices.  Additionally, customs entry review and Foreign Supplier Verification Program (FSVP) checks may experience slow processing, leading to potential shipment delays.  A prolonged shutdown could also have a significant impact on the Supplemental Nutrition Assistance Program (SNAP).  The effect on the Supplemental Nutrition Program for Women, Infants, and Children (WIC) food programs will be dependent on whether states can access other contingency funds. 
  • Keller and Heckman will continue to provide updates regarding the government shutdown and its implications.
  • On September 12, 2025, the U.S. Food and Drug Administration (FDA) expanded its public health alert concerning ground cinnamon products after detecting elevated levels of lead in several brands. This action is part of the agency’s ongoing investigation into lead contamination in food, which now includes Jiva Organics ground cinnamon. Testing revealed that this product contained 2.29 parts per million (ppm) of lead.
  • This is the second expansion of a recall that was initiated on March 6, 2024, and subsequently expanded on July 25, 2024. 
  • These alerts follow intensified FDA testing prompted by a 2023 incident involving lead-contaminated cinnamon applesauce pouches marketed to children. That event resulted in over 400 cases of lead poisoning among infants and young children.
  • Lead is a toxic heavy metal that can accumulate in the body over time, particularly in children, where it may cause developmental delays, behavioral issues, and reduced IQ. In response, FDA has identified elevated lead levels in at least 11 ground cinnamon brands, with concentrations ranging from 2.03 to 7.68 ppm. (See our previous blogs: FDA Issues Warning Letter to Austrofoods S.A.S and FDA Continues Response to Contaminated Applesauce Pouches.)
  • FDA continues to collaborate with state partners to test cinnamon sold directly to retail and at import. These efforts are part of the agency’s broader commitment to food safety and its “Closer to Zero” initiative aimed at reducing exposure to toxic elements in foods consumed by young children.
  • Keller and Heckman will continue to monitor and relay any developments in this area.
  • In Federal Register notices published on July 30, 2025, FDA announced user fees for fiscal year (FY) 2026 for several of its food programs operating under the Food Safety Modernization Act (FSMA).  These include:
  • FDA’s third-party certification program (90 FR 35906 (July 30, 2025)). The FD&C Act directs to FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities. The FD&C Act also directs FDA to establish a reimbursement (user fee) program to assess fees and require reimbursement for FDA’s work in administering this third-party certification program.
    • User fees for the third-party certification program are determined based on estimated costs, considering factors such as hours worked, travel costs, and inflation. Based on its estimated cost assessment, FDA set user fees for the certification program as follows:
      • Initial application fee for accreditation body seeking recognition: $53,440
      • Annual fee for recognized accreditation body: $2,498
      • Annual fee for accredited certification body: $3,122
      • Initial application fee for a certification body seeking direct accreditation from FDA: $53,440
      • Renewal application fee for recognized accreditation body: $32,724
  • FDA’s voluntary qualified import program (VQIP) (90 FR 35863 (July 30, 2025)). FDA also announced the 2026 user fee of $9,620 for its voluntary qualified importer program (VQIP). VQIP provides expedited review and import entry of food entering the U.S. from participating importers.
  • Certain reinspections and failures to comply with recall orders (90 FR 35910 (July 30, 2025)). FDA announced 2026 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections. These fees will be charged based on time spent by FDA at an hourly rate of $339 if domestic travel is required and $376 is foreign travel is required.
  • The Reagan-Udall Foundation (RUF) has released its Roadmap to Produce Safety: Summary of the Produce Safety Dialogue, which reflects input from produce sector stakeholders and is intended to serve as a “foundation for transformative change in produce safety management through collaboration.”
  • According to the Roadmap, “the burden of illness associated with microbial and chemical contamination of fresh produce is the most significant and disruptive food safety problem still affecting the U.S. food system,” while fresh produce is also a category that consumers are encouraged to consume more of as part of a healthy diet.
  • The Roadmap makes two primary recommendations to promote the availability of safe produce despite numerous foodborne illnesses and recalls challenging consumer trust and confidence:
    • First, the produce supply chain should “implement a shared responsibility approach,” in which all stakeholders actively participate in risk-based produce safety efforts.
    • Second, the supply chain should “form a structured, stakeholder led collaboration . . . led by influential stakeholders representing the diversity of the produce supply chain.”
  • FDA has stated its commitment to engagement and collaboration with stakeholders to implement strategies to prevent foodborne illness from produce, including seeking executive leadership of the Office of Produce Safety, established under the 2024 reorganization of the Human Foods Program, which we previously blogged about.
  • Keller and Heckman will continue to report on activities related to produce safety.
  • On December 11, 2024, the U.S. Food & Drug Administration (FDA) issued updated guidance for industry on the registration and listing of cosmetic product facilities and products.  The guidance provides recommendations and instructions to help individuals and companies comply with the Modernization of Cosmetics Regulations Act of 2022 (MoCRA).  
  • MoCRA mandates that cosmetic companies report serious adverse events to FDA within 15 business days, register their facilities and list their products, ensure product safety before marketing, and comply with FDA’s authority to access records and order recalls if products are found to be unsafe or misbranded.
  • The updated guidance outlines the statutory requirements for submitting cosmetic product facility registrations and product listings.  It finalizes the frequently asked questions (FAQs) in Appendix B (Q1-19) and introduces three new FAQs (Q20-22) for public comment.
    • Q20 outlines the responsibilities of a U.S agent, which includes assisting FDA with communications, responding to product inquiries, helping schedule inspections, and receiving documents on behalf of the foreign establishment;
    • Q21 explains that multiple buildings within three miles can share one FEI number if they are part of the same establishment and management, and can be inspected together; and
    • Q22 indicates that a product listing is generally required for all cosmetic products, including free samples or gifts, unless specific exemptions apply.  
  • The comment period is open until January 13, 2024, and comments can be submitted through the docket.  Keller and Heckman can assist in submitting comments and will continue to monitor developments related to MoCRA and cosmetics regulations.
  • On November 19, 2024, FDA issued a request for information on per- and polyfluoroalkyl substances (PFAS) in seafood in an effort to understand the potential for PFAS exposure from seafood and reduce dietary exposure to PFAS that may cause a health concern. According to FDA, seafood presents a unique challenge and opportunity to prevent contamination because many potential hazards can be introduced at the source, such as in growing areas, aquaculture farms, and on fishing vessels.
  • For purposes of this request, FDA defines “seafood” as fresh or saltwater finfish, crustaceans, other forms of aquatic life (e.g., alligator) other than birds or mammals, and all mollusks, which are intended for human consumption. Testing of samples in the general food supply has indicated that seafood may be at higher risk for environmental PFAS compared with other types of food. To expand on the results of these samples, FDA collected additional seafood samples of the most commonly consumed seafood in the United States, including clams, cod, crab, pollock, salmon, shrimp, tilapia, and canned tuna, most of which were imported. Based on perfluorooctanoic acid concentrations in canned clams from China, FDA concluded that their consumption is likely a human health concern, resulting in two voluntary recalls of canned clams from China.  Thus, FDA is requesting information to help enhance the Agency’s knowledge about the types of seafood prone to accumulate PFAS and harvest locations with PFAS contamination, ultimately supporting a comprehensive approach to advance clean air, water, and food.
  • Specifically, FDA is seeking data and information regarding PFAS concentrations in seafood, the environment, and processing water, as well as mitigation strategies for PFAS in seafood. FDA has provided specific questions for each of these categories to help identify where PFAS has been observed. The request for information will be published in the Federal Register on November 20, 2024, with a 90-day comment period ending February 18, 2025.
  • Comments can be submitted electronically on Regluations.gov to docket number FDA02024-N-4604. Keller and Heckman will continue to monitor developments in this area.