The U.S. Food and Drug Administration (FDA) has sent warning letters to four major retailers for not removing recalled baby formula from their shelves, even as it causes an increasing number of cases of infant botulism, resulting in the hospitalization of dozens of young children nationwide.
The letters, published on the agency’s website Monday and dated Dec. 12, were issued to national retailers Albertsons, Kroger, Target, and Walmart. These companies failed to stop selling ByHeart Whole Nutrition Infant Formula following the manufacturer’s notifying them of a recall in November, according to the FDA.
Infant botulism forms when infants consume spores of Clostridium botulinum bacteria, which multiply in intestines and release toxins into the child. Common symptoms entail constipation, lessened appetite, diminished head control, and difficulties swallowing. Severe instances can cause respiratory distress, requiring urgent medical care.
The Centers for Disease Control and Prevention reported last week that the outbreak has affected 51 infants in 19 states, with ages ranging from approximately two weeks to nearly nine months. Federal health officials recently broadened their investigation to encompass possible cases from late 2023 involving ByHeart formula, leading to the updated numbers released Dec. 11 by the FDA and CDC.
ByHeart recalled certain lots of its formula last month, then expanded it three days later on Nov. 11 to include all infant formula items, such as cans and single-serve stick packs.
“Consumers worldwide should not use any ByHeart brand infant formula as all ByHeart products are included in this recall,” the FDA said.
The outbreak, which federal and state authorities have been probing since November, became known in August with early reports of illnesses. By Nov. 22, it had climbed to 31 cases in 15 states. Every affected child became hospitalized, according to CDC data. Numbers then increased to more than 50 cases by early December. Officials noted that botulism is rare and treatable if caught early.
Parents of two infants who fell ill filed a lawsuit against ByHeart, alleging contaminated formula caused severe symptoms. One family’s daughter endured stomach pain and gas beginning Aug. 21, with her feedings decreasing until she refused food entirely, leading to hospitalization.
FDA inspections found recalled items on Walmart shelves in 21 states and Target stores in 20 states. In Arkansas, agency officials highlighted Target offering a $2 discount on the formula between Nov. 16 and Nov. 22.
Staff at various outlets said they were unaware of the recall and confused over which products had been recalled.
The agency gave the companies 15 working days to describe how they will avoid future failures to remove recalled products from their shelves. Noncompliance could lead to product confiscation.
Health experts have told parents to get rid of any ByHeart formula right away and contact a pediatrician if symptoms appear.
Reuters contributed to this report.
