Retailers didn't pull ByHeart baby formula fast enough after botulism recall, FDA says
Federal health officials criticized major retailers for failing to swiftly remove ByHeart baby formula linked to a botulism outbreak after a recall was issued on November 11, 2025. The FDA's warning letters highlighted that Walmart, Target, Kroger, and Albertsons continued to sell the contaminated formula for days, impacting over 50 infants across 19 states who were hospitalized with botulism. Despite the urgency of the situation, the FDA was also slow in sharing recall information with local authorities, which could have contributed to the delay in action. The retailers have 15 days to respond to the FDA's concerns, with implications for consumer trust and safety in the retail food supply chain. Moving forward, stricter compliance and prompt action in recall situations are essential to protect vulnerable populations, particularly infants.
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The FDA's warning letters were sent on December 12, 2025, to Walmart, Target, Kroger, and Albertsons, indicating that ByHeart infant formula remained on shelves even after the recall began.
ByHeart formula was found in Target stores in 20 states and was still sold in New Hampshire on November 16, despite having an electronic sales block in place.
Sales of ByHeart formula continued at Target in Arkansas with promotional discounts from November 16 to 22, even after the recall was issued.
Walmart reported that it had blocked sales of ByHeart formula at registers following the recall and removed the product from impacted stores.
The CDC expanded the outbreak's scope to include all infants treated for botulism linked to ByHeart formula produced since 2023, emphasizing the severity of the contamination.
The FDA's delay in sharing comprehensive product lists with state and local health officials, which only occurred on November 14, hindered timely action against the recalled products.
Steven Mandernach from the Association of Food and Drug Officials expressed disappointment over the lack of urgency in removing the contaminated formula from shelves, given the vulnerability of the affected infants.