FDA last week issued warning letters to retailers that continued selling recalled ByHeart infant formula, as part of a broader push to strengthen infant formula safety and improve recall effectiveness following a multistate infant botulism outbreak.
The enforcement action follows FDA’s investigation into cases of infant botulism linked to ByHeart powdered Whole Nutrition Infant Formula. ByHeart initiated a voluntary recall on Nov. 8, which was expanded on Nov. 11 to include all of its infant formula products. Despite the recall, FDA said inspections found recalled products still available for purchase weeks later.
According to the agency’s press announcement on Dec. 15, FDA and state partners conducted more than 4,000 retail checks nationwide, identifying recalled formula at over 175 retail locations across 36 states. In some instances, FDA said products remained on shelves for more than three weeks after retailers were notified of the recall.
FDA said the warning letters were issued to retailers that failed to remove the recalled product, reminding them of their responsibility under federal law to ensure recalled foods are promptly taken out of commerce.
Botulism investigation prompted expanded recall
The recall followed reports of infant botulism cases in multiple states. California health authorities detected Clostridium botulinum spores in product from an infant’s home, prompting further investigation and ultimately leading to the expanded recall of all ByHeart formula.
While ByHeart disputed the presence of the pathogen in commercially distributed products, FDA said the detection of the bacteria and the severity of infant botulism warranted broader action. The outbreak resulted in numerous hospitalizations and raised concerns about recall execution and communication across the infant formula supply chain.
FDA said it is continuing to work with federal, state and local partners to monitor recall effectiveness and ensure unsafe products are removed from the market.
The agency said it will continue monitoring compliance related to the ByHeart recall and may take additional action if recalled products remain on the market. The agency encouraged firms across the supply chain to review their recall procedures and ensure they are prepared to act quickly when safety issues arise.
The warning letters, FDA said, are intended to reinforce accountability and prevent future breakdowns in recall effectiveness for infant formula products.
FDA outlines steps to improve recall effectiveness
In the wake of the outbreak, FDA said it is taking steps to improve how recalls are carried out for infant formula and other foods consumed by vulnerable populations. In its announcement, the agency emphasized the importance of timely communication and coordination among manufacturers, distributors and retailers.
FDA said it is reinforcing expectations that companies across the supply chain maintain systems to rapidly identify affected products and verify their removal. The agency also reiterated that retailers play a critical role in recall execution once notified.
The actions align with FDA’s broader infant formula safety initiative, Operation Stork Speed, which the agency launched earlier this year. Operation Stork Speed is intended to strengthen oversight of infant formula through faster investigations, improved recall communications and updated evaluations of nutrients and contaminants.
FDA has said the initiative will also support modernization of regulatory processes for infant formula, including enhanced scientific review and collaboration with external partners.
Regulatory momentum for new formula pathway
The renewed focus on safety and recalls comes as FDA faces growing pressure to modernize oversight of the infant formula category more broadly. Last month, a federal funding package signed into law included congressional direction for FDA to streamline the regulatory pathway for non-dairy, non-soy plant-based infant formula.
Else Nutrition, manufacturer of plant-based foods for infants and children, said in a statement, the legislative language directs FDA to develop clearer and more efficient pathways for reviewing plant-based infant formulas, marking a significant step toward regulatory clarity for alternative formulations.
The directive complements FDA’s ongoing efforts under Operation Stork Speed to update how infant formulas are reviewed and monitored, as the agency balances expanding product options with heightened safety expectations.
