FDA warns that baby formula causing botulism in 39 infants is still available in stores

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  • Last update: 12/05/2025
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FDA warns that baby formula causing botulism in 39 infants is still available in stores

The Food and Drug Administration (FDA) has issued a warning that a baby formula connected to botulism cases in nearly 40 infants remains available at certain retailers, including Walmart and Target.

Back in November, ByHeart, an organic infant formula manufacturer, recalled its Whole Nutrition Infant Formula amid an ongoing federal probe into a nationwide outbreak of infant botulism that began in August. According to the Centers for Disease Control and Prevention (CDC), 39 babies in 18 states have been hospitalized so far, with Texas and California reporting the highest number of cases. No fatalities have been reported.

Despite the recall, the FDA reports that some stores are still displaying the product, putting infants at risk of exposure to Clostridium botulinum, the bacteria responsible for botulism. The CDC explains that infant botulism occurs when spores are ingested, germinate in the infants intestines, and produce toxins.

The FDA is actively collaborating with state authorities and retailers, including Walmart, Target, Kroger, Acme, and Shaws, to remove the formula from shelves.

Several families have filed lawsuits against ByHeart, claiming their children fell ill after consuming the contaminated formula. One parent described the harrowing experience of watching their infant suffer from the disease, emphasizing the unexpected severity of the illness. Other parents shared similar accounts of helplessness as their babies became dangerously weak.

Health officials advise parents and caregivers to avoid using ByHearts formula and to thoroughly clean any items or surfaces that may have come into contact with it. Infants who have consumed the formula should be monitored closely for symptoms, and medical attention should be sought immediately if signs of botulism appear.

The CDC lists symptoms of infant botulism as difficulty feeding, weak head control, trouble swallowing, and reduced facial expressions. Symptoms may take several weeks to manifest. If untreated, the condition can progress to flaccid paralysis, causing breathing difficulties and requiring extended hospitalization.

Addition from the author

Author's Commentary: Ongoing Risks Despite Recall

The recent FDA warning highlights a critical gap in the effectiveness of product recalls. Although ByHeart's Whole Nutrition Infant Formula was recalled in November, it continues to appear on shelves in major retailers, including Walmart and Target. This exposes infants to a severe risk of botulism, a condition that has already hospitalized 39 babies across 18 states.

Health authorities are clear: infant botulism can develop slowly, and symptoms such as weak head control, difficulty feeding, and reduced facial expressions may not appear immediately. The fact that contaminated formula remains accessible underscores the need for stricter enforcement and better communication between manufacturers, retailers, and federal agencies.

Parents and caregivers must remain vigilant. Any exposure should prompt immediate medical consultation, and affected items should be isolated and cleaned thoroughly. The ongoing lawsuits against ByHeart reflect the severity of the outbreak and the urgent necessity for systemic changes in product recall procedures.

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Sources:

Grace Ellison

Author: Grace Ellison
Grace Ellison is a journalist focusing on environmental issues and sustainability. She has experience publishing international reports and participating in documentary projects.

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