Contaminated Baby Formula Linked to Botulism Outbreak

Four of the nation's top retail stores, Walmart, Target, Kroger, and Albertsons, failed to promptly remove contaminated ByHeart infant formula linked to a botulism outbreak from their shelves, according to the U.S.

Food and Drug Administration. The FDA sent warning letters to the companies stating that they continued to sell the formula for days or weeks after a recall was issued on November 11, 2025. The outbreak has sickened more than 50 babies across 19 states.

Reports indicate that the formula was discovered at Target stores in 20 states long after the recall was initiated, with one Target store in New Hampshire selling the formula on November 16, despite an electronic block on the product's sales code.

Additionally, Target in Arkansas promoted single-serve packs of the formula with a sale sign and a $2 discount from November 16 to November 22. Walmart was noted to have sold the formula in 21 states from November 12 to November 26, while Albertsons and Kroger had sales of the product in 11 and 10 states, respectively, during the same period.

The FDA criticized these companies for not providing evidence of corrective actions taken in response to the recall. Walmart stated that no ByHeart formula was sold after their registers were blocked following the recall, while Albertsons asserted that they worked closely with suppliers and regulators to remove the products.

All affected babies have been hospitalized and treated with IV medication to halt the disease's progression. The Centers for Disease Control and Prevention expanded the outbreak to include all infants treated for botulism after consuming ByHeart formula since production began in 2023.

Steven Mandernach, executive director at the Association of Food and Drug Officials, expressed disappointment at the FDA's slow communication regarding the recall, stating that the agency didn't fully share product lists until November 14, nearly a week after the initial recall of two lots of ByHeart formula on November 8.

He emphasized the lack of urgency to ensure the safety of a product that is the sole source of nutrition for vulnerable infants.