FDA Warns Major Retailers for Slow Halt of Recalled ByHeart Formula Sales
Recent warnings from the U.S. Food and Drug Administration (FDA) spotlight major retailers for their delayed response in removing recalled ByHeart infant formula linked to a severe botulism outbreak. The FDA issued letters to Walmart, Target, Kroger, and Albertsons, indicating that these companies continued to sell the contaminated formula after a recall was initiated on November 11, affecting over 50 infants across 19 states.
Details of the Recalled ByHeart Formula
The FDA initiated a recall of ByHeart infant formula due to significant health concerns. Federal officials alerted the retailers that they failed to act swiftly, with products remaining on shelves days or even weeks after the recall announcement.
Retailers Involved in the Recall
- Walmart: Sold ByHeart formula in 21 states from November 12 to November 26.
- Target: Continued sales in 20 states, with incidents reported even after a sales block was implemented and promotional discounts were offered.
- Kroger: Found selling the formula in 10 states from November 12 to November 19.
- Albertsons: Continued sales in 11 states from November 12 to November 19.
Regulatory Actions and Responses
FDA officials demanded evidence of corrective actions from the retailers in their warning letters sent on December 12. The companies were given 15 working days to respond. Walmart stated they promptly restricted sales after the recall, claiming no products were sold post-restriction. Albertsons mentioned efforts to cooperate closely with suppliers and regulators to eliminate the recalled formula.
Health Impact and Ongoing Crisis
All infants affected by the outbreak have been hospitalized and received intravenous medication to counter the botulism threat. According to the Centers for Disease Control and Prevention (CDC), the outbreak encompasses all infants treated for botulism since ByHeart’s production began in 2023. The FDA has confirmed no evidence of recalled formula on store shelves since November 26, 2025.
Industry Concerns
Concerns within the food safety community have emerged, highlighted by Steven Mandernach, executive director at the Association of Food and Drug Officials. He criticized the FDA for delayed information dissemination regarding the recall. The agency only fully shared product lists nearly a week after the initial alert on November 8, which raised alarms about the urgency needed to protect vulnerable infants.
This situation serves as a critical reminder of the responsibilities held by retailers in managing product recalls effectively, especially when the health of infants is at stake.
