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FDA says big retailers didn’t adopt BayHeart baby formula fast enough after botulism recall

KANIKA SINGH RATHORE, 16/12/202516/12/2025

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Four of the nation’s top retail stores failed to immediately remove contaminated infant formula linked to an outbreak of dangerous botulism, federal health officials said in warning letters posted Monday.

US Food and Drug Administration sent letters to leaders wal-mart, TargetKroger and Albertsons said the companies continued to sell BayHeart infant formula for several days or weeks despite recalling all products on November 11, which sickened more than 50 children in 19 states.

“As a partner in the supply chain, your company must take prompt and effective action when notified of a product recall.” fda Authorities said in warning letters sent to companies on Dec. 12 and posted online on Monday.

The formula was found at Target stores in 20 states “long after the recall was initiated,” a letter said. Also, it was sold at a Target store new Hampshire On November 16, the FDA noted, despite the electronic block on the product’s sales code. And at a Target store arkansasSingle-serve packs of Bayheart Formula are labeled “SALE!” Was promoted with. Sign up and get $2 off from November 16th to November 22nd.

Information from state and local health officials says the BayHeart formula was found in Walmart stores in 21 states from Nov. 12 to Nov. 26. The formula was found 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.

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Additionally, despite multiple requests, the companies failed to provide the FDA with evidence that corrective actions had been taken, the agency said. Companies have 15 working days to respond to the letters.

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

“We acted quickly to issue a sales restriction and removed this product from our affected 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 with customers.

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

All infants diagnosed with the disease have been hospitalized and treated with IV medication to prevent disease progression. The U.S. Centers for Disease Control and Prevention expanded the outbreak in 2023 to include all infants treated for botulism after consuming Bayheart formula since it was first produced.

Steven Mandernach, executive director of 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 did not share full product lists until November 14 – about a week after the initial recall of two lots of Bayheart formula on November 8.

He said it was “disappointing” to have the outbreak linked to the only source of nutrition for vulnerable infants.

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“There probably wasn’t the urgency to make sure the product was out on the market that I expected,” Mandernach said.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. AP is solely responsible for all content.

Uk adoptbabyBayHeartbigbotulismdidntFastFDAformularecallretailers

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