In a series of warning letters posted Monday, the U.S. Food and Drug Administration accused four of the nation’s biggest grocery chains of keeping contaminated ByHeart infant formula on shelves weeks after a recall that has sickened more than 50 babies.
FDA Warning Letters to Major Retailers
The FDA sent letters to leaders at Walmart, Target, Kroger and Albertsons on Dec. 12, warning that the companies had not promptly removed ByHeart infant formula after a recall initiated on Nov. 11. The recall followed a botulism outbreak that sickened more than 50 babies in 19 states.
Target’s Continued Sales
A letter to Target noted that the formula was found in 20 states “well after the recall was initiated.” It also highlighted a store in New Hampshire where the product was sold on Nov. 16 despite an electronic block on the sales code. In Arkansas, single‑serve packs were promoted with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.
Walmart, Kroger and Albertsons Findings
Walmart stores carried the product in 21 states from Nov. 12 to Nov. 26. Albertsons had ByHeart on shelves in 11 states between Nov. 12 and Nov. 19, while Kroger’s stores sold the formula in 10 states during the same period.
Company Responses
Walmart officials said no ByHeart formula was sold after cash registers were blocked. “We moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online,” a company spokesperson said in an email. “We take all reports of inaction seriously and will respond to the letter.”
Albertsons said it worked closely with suppliers and regulators to identify and remove the products. “ByHeart infant formula products have been removed from our store shelves,” the company said in a statement.
FDA and CDC Actions
All babies in the outbreak have been hospitalized and treated with an IV medication to halt the disease. The Centers for Disease Control and Prevention expanded the outbreak to include every infant treated for botulism after consuming ByHeart formula since it first entered production in 2023.
Industry Commentary
Steven Mandernach, executive director at the Association of Food and Drug Officials, criticized the FDA’s pace. He said the agency was slow to distribute recall information, not fully sharing product lists until Nov. 14—nearly a week after the initial recall of two lots on Nov. 8. “It was disappointing,” Mandernach said. “There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect.”
Key Takeaways
- Four major retailers were warned for failing to pull contaminated ByHeart formula after a recall.
- The product remained on shelves in multiple states for weeks, even after electronic blocks were in place.
- Babies treated for botulism have all been hospitalized; the outbreak now covers every infant exposed to ByHeart formula since 2023.
The FDA has given the companies 15 working days to respond, demanding evidence of corrective actions.
Morgan J. Carter is a Texas-based journalist covering breaking news, local government, public safety, and community developments across Austin. With more than six years of reporting experience, Morgan focuses on delivering accurate, clear, and timely stories that reflect the fast-moving pulse of the city.
At newsofaustin.com, Morgan reports on everything from severe weather alerts and traffic updates to city council decisions, crime reports, and the issues shaping daily life in Austin. Known for reliable fact-checking and a strong commitment to public-interest journalism, Morgan brings readers the information they need to stay informed and engaged.
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