The Food and Drug Administration (FDA) has issued a critical warning regarding baby formula linked to a botulism outbreak that has affected at least 39 infants across the United States. The formula, produced by organic infant formula maker ByHeart, remains available on store shelves at major retailers such as Walmart and Target, despite a recall initiated in November 2023.
Since August 2023, the outbreak has prompted an investigation by the Centers for Disease Control and Prevention (CDC), which confirmed that babies in 18 states have been hospitalized due to infant botulism. Texas and California, the two most populous states, report the highest number of cases. Fortunately, there have been no reported deaths linked to this outbreak.
Parents are understandably concerned as they navigate the risks associated with the formula, which may contain Clostridium botulinum, the bacteria responsible for the disease. The CDC explains that botulism in infants occurs when spores are ingested, leading to toxin production in the gut.
Ongoing Risk in Retail Stores
Despite the FDA’s notifications, reports indicate that the recalled formula continues to be sold at multiple retailers, including Kroger, Acme, and Shaw’s. The agency is actively collaborating with state partners and retailers to ensure the affected products are removed from shelves. As this situation unfolds, the FDA remains vigilant in monitoring reports of the recalled formula still being available for purchase.
Families impacted by the contaminated formula are taking legal action against ByHeart. At least four lawsuits have emerged, with parents claiming that their infants suffered serious health consequences after consuming the formula. Stephen Dexter, a father from Arizona, shared the harrowing experience of his daughter, who spent weeks hospitalized due to botulism. He expressed disbelief that a product designed for vulnerable infants could result in such severe illness.
In another case, Hanna Everett from Kentucky described the emotional toll of watching her infant daughter, Piper, struggle with symptoms of the disease. “She’s so little and you’re just helplessly watching this,” she told the Associated Press.
Health Guidelines for Concerned Parents
The CDC urges parents and caregivers to refrain from using ByHeart’s Whole Nutrition Infant Formula and to thoroughly clean any surfaces or items that may have come into contact with it. If an infant has consumed the formula and displays symptoms of botulism, immediate medical attention is advised. Symptoms can include poor feeding, loss of head control, difficulty swallowing, and reduced facial expression.
The CDC notes that symptoms may take several weeks to appear. Untreated, the condition can lead to progressive flaccid paralysis and potentially serious respiratory complications, necessitating extended hospitalization.
As this alarming situation continues to develop, parents are encouraged to remain vigilant and informed. The FDA and CDC are working to minimize risks and ensure the safety of infants across the country.
