December 15, 2025 - FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula

The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and called for industry to increase adoption of best practices in recall implementation, especially for recalls involving foods for our country's most vulnerable populations -infants and young children. Last week, the FDA sent warning letters to several major retailers for failing to remove recalled ByHeart infant formula from their store shelves despite being notified of the recall. These warning letters highlight a concerning problem with recall effectiveness at the retail level. Last year, the FDA sent a similar warning letter to a retailer who failed to adequately remove recalled lead-contaminated WanaBana apple cinnamon fruit puree pouches from its store shelves.

In the weeks following the manufacturer's voluntary recall of ByHeart infant formula products, FDA investigators and state and local partners checked retail stores across the U.S. over 4,000 times to ensure recalled product was not being made available to consumers. Through this effort, we found that recalled infant formula continued to be found on store shelves-for over three weeks in one case, in over 175 locations across 36 states. These warning letters highlight the critical responsibility that retailers have in effectuating a recall, particularly when dealing with products that pose serious health risks to our most vulnerable populations, such as infants.

"Food safety is a shared responsibility, and it is of utmost importance that all parties in the supply chain act swiftly and vigilantly to protect our nation's children from unsafe food," said FDA Commissioner Marty Makary, M.D., M.P.H.

When a food is recalled, every industry member along the supply chain plays an important role in carrying out the recall. Retailers play the especially crucial role in the last step of the supply chain by ensuring that recalled products are immediately removed and not available to consumers at their stores. The agency is particularly concerned with these retailers' capability to quickly remove unsafe products from their store shelves and ensure it remains off shelves as required during a public health emergency. The FDA has asked these retailers to respond to the warning letters within 15 days stating the specific steps they have taken to address any violations and prevent the recurrence of violations, or providing its reasoning and supporting information as to why the company believes it is not in violation of the law.

Today's letter to industry builds on the FDA's steps to advance the evolution of industry and government recall systems to transform how we work together to collect, analyze, and disseminate crucial recall information. Earlier this year, agency leadership called for increased attention to product recall communications from industry leaders involved in the manufacturing and distribution of infant formula, baby foods and foods intended for children. Additionally, under the efforts of Operation Stork Speed, the FDA continues to ensure that caregivers of infants and young children can have confidence that infant formula is safe and consistently available.

The FDA, in collaboration with the Centers for Disease Control and Prevention, the California Department of Public Health Infant Botulism Treatment and Prevention Program, and state and local partners, has been investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. ByHeart Inc.'s voluntary recall began on Nov. 8, 2025, and was expanded on Nov. 11, 2025, to include all ByHeart Whole Nutrition Infant Formula products. The FDA has not received reports of recalled formula being found on store shelves since November 26, 2025.

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