Big retailers didnt pull ByHeart baby formula fast enough after botulism recall, FDA says

Four of the country’s top retailers failed to immediately recall contaminated infant formula. dangerous botulism epidemic It has been removed from shelves, federal health officials said in warning letters issued Monday.

The U.S. Food and Drug Administration sent letters to leaders of Walmart, Target, Kroger and Albertsons, saying the companies continued to sell ByHeart baby food for days or weeks despite the Nov. 11 recall. all products More than 50 babies fell ill in the outbreak in 19 states.

“As a participant in the supply chain, your company must take action quickly and effectively in the event of a product recall,” FDA officials said in warning letters sent to companies on December 12 and published online on Monday.

The formula was found in Target stores in 20 states “long after the recall was initiated,” a letter said. Additionally, the FDA noted that the product was sold at a Target store in New Hampshire on November 16 despite electronic blocking in the sales code. And at a Target store in Arkansas, single-serve packs of the ByHeart formula were sold with a “Sale!” was introduced with. sign and a $2 discount from November 16th to November 22nd.

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

It was also stated that despite numerous requests, the companies failed to provide the FDA with evidence that corrective measures were taken. Companies have 15 business 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 took swift action to restrict sales and removed this product from our 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 is working closely with suppliers and regulators to identify and remove products and communicate with customers.

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

All babies in the outbreak were hospitalized Treated with IV medication to stop the progression of the disease. US Centers for Disease Control and Prevention expanded the scope of the outbreak All babies treated for botulism After consuming the ByHeart formula since 2023 when it was first produced.

Steven Mandernach, executive director of the Association of Food and Drug Officials, said the FDA was slow to distribute information about the recall to state and local food safety officials. The agency did not share full product listings until Nov. 14, nearly a week after the initial recall of two batches of ByHeart formula on Nov. 8.

He said it was “disappointing” that an outbreak was the only source of nutrition for vulnerable babies.

“There probably wasn’t a sense of urgency to get the product taken off the market,” Mandernach said.

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