Baby Formula Recall: Retailers Failed to Act Promptly, FDA Warns (2026)

Retailers' Slow Response to Botulism Recall Leaves Infants at Risk

The U.S. Food and Drug Administration (FDA) has issued a stark warning to four major retailers: Walmart, Target, Kroger, and Albertsons. The agency's investigation revealed that these companies failed to promptly remove contaminated ByHeart baby formula from their shelves after a botulism outbreak sickened over 50 infants across 19 states. The outbreak, linked to two lots of ByHeart formula, was first recalled on November 8, 2023.

Despite the urgent nature of the recall, the FDA found that these retailers continued selling the affected formula for days or weeks. For instance, Target stores in 20 states sold ByHeart formula well after the recall, with one store in New Hampshire selling it as late as November 16, even though an electronic block was in place to prevent sales. In Arkansas, Target promoted single-serve packs of ByHeart formula with a "Sale!" sign and a $2 discount from November 16 to November 22.

Walmart stores in 21 states and Albertsons stores in 11 states also sold the contaminated formula from November 12 to November 26 and November 12 to November 19, respectively. Kroger stores in 10 states sold the formula during the same period.

The FDA's warning letters emphasize the retailers' responsibility to act promptly when notified of a product recall. However, the companies have yet to provide evidence of corrective actions, despite multiple requests from the FDA. The affected retailers have 15 working days to respond to the letters.

This delay in removing the contaminated formula from the market has raised concerns among health officials. The outbreak has led to the hospitalization of all affected infants, who were treated with IV medication to halt the progression of botulism. The U.S. Centers for Disease Control and Prevention expanded the outbreak to include all babies treated for botulism after consuming ByHeart formula since its production in 2023.

The Association of Food and Drug Officials' executive director, Steven Mandernach, criticized the FDA's slow distribution of recall information to state and local food safety officials. The agency didn't fully share product lists until November 14, nearly a week after the initial recall. Mandernach expressed disappointment, especially given the critical nature of the outbreak affecting vulnerable infants.

This incident highlights the importance of swift action in product recalls to protect public health. The retailers' delay in removing the contaminated formula from the market raises questions about their response protocols and the potential impact on consumer safety.

Baby Formula Recall: Retailers Failed to Act Promptly, FDA Warns (2026)
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