Retailers didn’t pull ByHeart baby formula fast enough after botulism recall, FDA says

Four of the nation’s top retail stores failed to promptly pull contaminated infant formula tied to a dangerous botulism outbreak from their shelves, federal health officials said in warning letters posted Monday.

The U.S. Food and Drug Administration sent letters to leaders at Walmart, Target, Kroger and Albertsons, saying the companies continued to sell ByHeart infant formula for days or weeks, despite a Nov. 11 recall of all products in the outbreak that has sickened more than 50 babies in 19 states.

“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” FDA officials said in warning letters sent to the companies on Dec. 12 and posted online Monday.

The formula was found at Target stores in 20 states “well after the recall was initiated,” one letter said. In addition, it was sold at a Target store in New Hampshire on Nov. 16, despite an electronic block on the product’s sales code, the FDA noted. And at a Target store in Arkansas, single-serve packs of ByHeart formula were promoted with a “Sale!” sign and a $2 discount from Nov. 16 to Nov. 22.

Information from state and local health officials said ByHeart formula was found at Walmart stores in 21 states from Nov. 12 to Nov. 26. The formula was found in Albertsons stores in 11 states from Nov. 12 to Nov. 19, and at Kroger stores in 10 states from Nov. 12 to Nov. 19.

In addition, the companies failed to provide FDA with evidence that corrective actions have been put in place, despite multiple requests, the agency said. The companies have 15 working days to respond to the letters.

Walmart officials said in a statement that no ByHeart formula was sold after cash registers were blocked from selling the formula following the recall.

“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 officials said the company worked closely with suppliers and regulators to identify and remove the products and communicate to customers.

“ByHeart infant formula products have been removed from our store shelves,” the company said in a statement.

All of the babies in the outbreak have been hospitalized and treated with an IV medication to stop the progress of the disease. The U.S. Centers for Disease Control and Prevention expanded the outbreak to include all babies treated for botulism after consuming ByHeart formula since it was first produced in 2023.

Steven Mandernach, executive director at the Association of Food and Drug Officials, said the FDA itself was slow to distribute information about the recall with state and local food safety officials. The agency didn’t fully share product lists until Nov. 14 — nearly a week after the initial recall of two lots of ByHeart formula on Nov. 8.

He said it was “disappointing” in an outbreak involving the sole source of nutrition for vulnerable infants.

“There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect,” Mandernach said.