FDA calls for improved retail recall compliance to protect infants and young children

The FDA has issued a reminder to the food industry regarding its legal responsibilities under the Federal Food, Drug, and Cosmetic Act, emphasizing the need for more effective implementation of food recalls, particularly for products intended for infants and young children. The agency’s action follows recent warning letters sent to several major retailers that failed to promptly remove recalled infant formula products from store shelves despite receiving formal notification of the recall.¹

According to the FDA, these warning letters underscore ongoing challenges with recall effectiveness at the retail level. In one recent case, retailers did not adequately remove ByHeart infant formula following a voluntary manufacturer recall.² This follows a similar enforcement action taken last year, when a retailer failed to remove lead-contaminated WanaBana apple cinnamon fruit puree pouches from store shelves. The FDA stated that such failures raise significant concerns about the ability of retailers to protect consumers during public health–related recalls.

FDA inspections reveal recalled infant formula remained on shelves

After the voluntary recall of ByHeart infant formula products, FDA investigators, in collaboration with state and local partners, conducted more than 4,000 retail inspections nationwide to verify that recalled products were no longer available for purchase. These inspections revealed that recalled infant formula remained on store shelves in over 175 locations across 36 states. In at least 1 instance, recalled products were still available more than three weeks after the recall was initiated. The agency characterized these findings as particularly concerning, given the vulnerability of the affected population.

“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, MD, MPH.

Retailers’ role in food recall execution emphasized by FDA

The FDA emphasized that food recalls require coordinated action across the entire supply chain, from manufacturers and distributors to retailers. While each participant has a role in recall execution, the agency highlighted that retailers are responsible for the final step—ensuring recalled products are immediately removed from shelves and remain unavailable to consumers. This responsibility is especially critical during public health emergencies involving products that pose serious risks to infants and young children.

FDA requests corrective actions following retail warning letters

In its warning letters, the FDA expressed concern about retailers’ systems and procedures for rapidly identifying, removing, and tracking recalled products. The agency has required recipients of the warning letters to respond within 15 days, detailing the specific corrective actions taken to address the violations and prevent recurrence. Alternatively, companies may provide a justification, along with supporting documentation, explaining why they believe they are not in violation of federal law.

FDA efforts to modernize food recall systems continue

The FDA noted that the current action builds on broader agency efforts to modernize and strengthen recall systems across industry and government. Earlier this year, FDA leadership called for increased attention to recall communications among manufacturers and distributors of infant formula, baby foods, and foods intended for children. These efforts aim to improve how recall information is collected, analyzed, and shared to ensure faster and more reliable removal of unsafe products from the market.

Operation Stork Speed focuses on infant formula safety and availability

The agency also linked these activities to its ongoing Operation Stork Speed initiative, which focuses on ensuring that infant formula is both safe and consistently available. Through this initiative, the FDA has worked to enhance oversight of infant formula manufacturing and supply chains while supporting caregiver confidence in the safety of products available for infant feeding.³

Investigation continues into infant botulism linked to ByHeart formula

In parallel with enforcement and oversight activities, the FDA continues to investigate a multistate outbreak of infant botulism associated with ByHeart Whole Nutrition Infant Formula. This investigation is being conducted 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. ByHeart Inc. initiated a voluntary recall of its Whole Nutrition Infant Formula products on November 8, 2025, and expanded the recall on November 11, 2025, to include all products under that designation.

The FDA reported that it has not received any additional reports of recalled ByHeart infant formula being found on store shelves since November 26, 2025. The agency stated that it will continue to monitor retailer compliance and work with industry stakeholders to strengthen recall execution, particularly for foods intended for infants and young children, where delays or failures can carry significant health consequences.

References

1. FDA. FDA Takes Action to Improve Recall Effectiveness Following Infant Botulism Outbreak Investigation Linked to ByHeart Infant Formula. FDA. December 15, 2025. Accessed December 15, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-action-improve-recall-effectiveness-following-infant-botulism-outbreak-investigation
2. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). FDA. Press release. November 11, 2025. Accessed December 15, 2025. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025
3. HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families. FDA. Press release. March 18, 2025. Accessed December 15, 2025. https://content.govdelivery.com/accounts/USFDA/bulletins/3d78943