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• Posted December 17, 2025

FDA Slams Retailers for Keeping Recalled Infant Formula on Shelves

Some of the nation’s biggest retailers are receiving stern warning letters after regulators found recalled baby formula still being sold weeks after it was pulled for safety concerns.

The U.S. Food and Drug Administration (FDA) sent warning letters to Walmart, Target, Kroger and Albertsons, saying investigators found that stores continued selling recalled infant formula tied to a growing botulism outbreak.

The product, ByHeart Whole Nutrition Infant Formula, had been linked to at least 51 suspected or confirmed cases of infant botulism in 19 states as of Dec. 10, according to federal officials.

The FDA said retailers were first notified of the recall Nov. 8, after health officials determined the formula was the likely source of the outbreak. 

The company expanded the recall to all ByHeart products on Nov. 11.

Despite those warnings, the FDA said some stores kept the formula on shelves for weeks. 

At Target locations, the product was still being sold more than two weeks after the recall, in some cases with discount signs still displayed, the agency said.

In addition to Target, the FDA also criticized Walmart, Kroger and Albertsons for failing to provide proof that they had taken steps to fix the problem, despite repeated follow-up calls and emails.

“Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction,” the letters stated.

The U.S. Centers for Disease Control and Prevention (CDC) has called the situation “unprecedented,” noting it is the first known outbreak of infant botulism tied to formula.

Infant botulism happens when babies swallow spores of Clostridium botulinum bacteria, which then release dangerous toxins in the intestines.

Symptoms can include poor feeding, weak crying, loss of head control and trouble breathing or swallowing. Symptoms may appear days or even weeks after exposure.

The CDC urges parents to seek medical care right away if a baby consumed the recalled formula and shows symptoms.

In a statement, Walmart said it plans to respond to the FDA and takes “all reports of inaction seriously," The Washington Post said.

“When notified of the recall, we moved swiftly to issue a sales restriction and removed this product from our impacted stores and clubs and online,” the statement said.

Target, Kroger and Albertsons did not immediately respond to requests from The Post for comment.

More information

The Mayo Clinic has more on botulism.

SOURCE: The Washington Post, Dec. 16, 2025