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Four leading retail chains—Walmart, Target, Kroger, and Albertsons—have been reprimanded by federal health authorities for not promptly removing contaminated ByHeart infant formula from their shelves. The U.S. Food and Drug Administration (FDA) issued warning letters to these companies, highlighting that despite a recall announced on November 11, the formula linked to a botulism outbreak remained available for sale for several days or weeks afterward.
The botulism outbreak has resulted in the hospitalization of over 50 infants across 19 states, all of whom required intravenous treatment to halt disease progression. The recall covers all ByHeart products involved in the outbreak.
According to the FDA, the recalled formula was still found in Target stores across 20 states well beyond the recall date. In one New Hampshire Target store, it was sold even on November 16, despite electronic sales restrictions being in place. Furthermore, a Target store in Arkansas continued to promote and discount single-serve ByHeart formula from November 16 through November 22.
Walmart stores reported the presence of the formula in 21 states between November 12 and November 26. Similarly, Albertsons carried the product in 11 states, and Kroger in 10 states, from November 12 to November 19.
The FDA also expressed concern that the retailers have yet to provide evidence of corrective measures following multiple agency requests. The companies have been given 15 working days to respond to the letters.
In response, Walmart stated that it swiftly halted sales by blocking the product at cash registers once the recall was issued and removed the formula from affected stores and online platforms. Albertsons confirmed its cooperation with suppliers and regulators to promptly take the product off shelves and inform customers.
Officials from food safety agencies have critiqued the FDA for a delayed distribution of recall information to state and local authorities. The agency did not fully release product lists until November 14, nearly a week after initially recalling two lots of ByHeart formula on November 8, which slowed the response to the outbreak. Experts underscored the urgency expected when vulnerable infants’ sole nutrition source is impacted.
The Centers for Disease Control and Prevention (CDC) expanded the case definition to include all infants receiving botulism treatment following consumption of ByHeart formula since production began in 2023.
