FDA says ByHeart baby formula recall response was too slow : NPR

Four of the nation's largest retail stores failed to quickly remove contaminated infant formula from their shelves linked to a dangerous botulism outbreak, federal health officials said in warning letters issued Monday.

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

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

The formula was found in Target stores in 20 states “well before the recall began,” one letter said. Additionally, on November 16, it was sold at a Target store in New Hampshire despite electronically blocking the product's sales code, the FDA noted. And at a Target store in Arkansas, single-serving containers of ByHeart formula were advertised with the words “On Sale!” sign and $2 off from November 16th to 22nd.

The ByHeart formula was found in Walmart stores in 21 states between November 12 and November 26, according to state and local health officials. The formula was found in Albertsons stores in 11 states from November 12 to 19 and in Kroger stores in 10 states from November 12 to 19.

In addition, the companies failed to provide the FDA with evidence of corrective action taken, despite numerous requests, the agency said. Companies have 15 working days to respond to 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 promptly implemented a sales restriction and removed this product from affected stores, 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 products and keep customers informed.

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

All infants during the outbreak were hospitalized and received intravenous treatment to stop the progression of the disease. The US Centers for Disease Control and Prevention has expanded the outbreak to include all children treated for botulism after consuming ByHeart formula since it was first produced in 2023.

Stephen Mandernak, executive director of the Association of Food and Drug Officials, said the FDA itself was slow to disseminate information about the recall to state and local food safety officials. The agency did not fully disclose the product listings until Nov. 14—nearly a week after the initial recall of two lots of ByHeart formula on Nov. 8.

He said it was “disappointing” that the outbreak had affected the only source of nutrition for vulnerable infants.

“There probably wasn’t the same urgency to ensure that the product was taken off the market as I expected,” Mandernach said.