The U.S. Food and Drug Administration sent stern warning letters to Walmart, Target and other retail giants after its investigators found they had kept baby formula on store shelves even after the product had been recalled due to its links to an outbreak of infant botulism.
In letters released Monday, the FDA also warned Kroger and Albertsons about their continued sales of ByHeart Whole Nutrition Infant Formula, which was linked to at least 51 cases of suspected or confirmed infant botulism across 19 states as of Dec. 10.
The FDA criticized Target’s response to the recall as inadequate, pointing out that the formula was sold with promotional discount signage more than two weeks after the first wave of recalls. It also said that Target, Walmart, Kroger and Albertsons failed to provide “any information demonstrating corrective actions” in numerous follow-up email exchanges initiated by the FDA after it held calls with the retailers to discuss the matter.
“Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction,” the letters warned.
Jennifer Cope, who heads the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention, has called the outbreak “unprecedented.” The agency says it is the first-ever infant botulism outbreak.
The CDC has determined that the formula was the source of the outbreak, the FDA letters state, and major retailers were notified of the initial recall on Nov. 8. ByHeart later issued a wider recall of all of its products on Nov. 11.
Despite this, Target continued to sell the recalled formula in stores across 20 states “well after the recall was initiated and subsequently expanded,” one FDA letter reads, as did Kroger and some of their affiliate stores in 10 states. Albertsons also sold formula well after the recall in 11 states, the FDA said, while Walmart continued to sell the formula across 21 states.
“As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall,” the FDA stated in letters to all four companies.
Star Market, Jewel-Osco, Acme, Safeway and Shaw’s are owned by Albertsonsand had the formula available for purchase after the recall. King Soopers and Smith’s Food and Drug, both owned by Kroger, also displayed the recalled formula.
Infant botulism, which can be fatal in rare cases, is contracted when swallowed spores from Clostridium botulinum bacteria produce toxins in a baby’s large intestine, according to the CDC. Symptoms include poor feeding, loss of head control, difficulties with swallowing and breathing, decreased facial expression and a weak and altered cry. The symptoms can take as long as several weeks to develop.
The CDC has urged parents and caregivers to seek immediate care if a child has consumed the recalled product and is experiencing any of the symptoms.
In an emailed statement, Walmart said it would respond to the letter and that it took “all reports of inaction seriously.” “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,” it said.
Target, Kroger and Albertsons did not immediately respond to a request for comment.
Jennifer Hassan contributed to this report.
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