The CDC Warns Parents About a Possible Botulism Outbreak Linked to Baby Formula

Watching your baby get sick is every parent's worst nightmare. But finding out that your baby fell ill with a potentially life-threatening condition because of something they ate can be a whole different horror, especially when you know that it was preventable. That's an experience that the parents of more than a dozen infants are going through due to a suspected botulism outbreak.

According to the U.S. Centers for Disease Control and Prevention (CDC), a multistate outbreak occurred in 2025.

The organization says that it is working with the Infant Botulism Treatment and Prevention Program, as well as the U.S. Food and Drug Administration (FDA), to ensure that any contaminated items have been removed from shelves, and that consumers are aware of the possible risks associated with using the recalled items.

Keep reading to learn what the CDC is saying about the baby formula outbreak, including which products have been recalled as part of the investigation.

ByHeart, Inc. is taking part in a voluntary recall of two different lots of its Whole Nutrition Infant Formula. The products were sold across the country, and is estimated to make up around one percent of the total sales of formula within the U.S., according to the CDC.

The following products have been recalled, each of which has a UPC of 5004496800:

• Lot number 206VABP/251261P2, which has a use-by date of "01 Dec 2026."
• Lot number 206VABP/251131P2, which has a use-by date of "01 Dec 2026."

The above information can be found on the bottom of the formula cans.

The FDA shared a Nov. 8, 2025 announcement about the recall, writing that an estimated 83 cases had been reported across the country since August 2025. Of those, 13 infants had been given ByHeart formula. While the FDA's statement said that the organization had not been able to identify a direct link between the formula and these cases, ByHeart has still issued a voluntary recall of the product.

According to the Cleveland Clinic, infant botulism only impacts children under the age of one. In the beginning, the symptoms are very easy to miss, and they begin with more subtle things like weak crying or constipation.

However, from there, babies can quickly get into trouble with more pronounced symptoms, which can include trouble treating and muscle weakness. Although very rare, the Cleveland Clinic says that the illness can be fatal without early (and fast) treatment.

You'll need to visit your healthcare provider for diagnosis. Once they have identified that a child has a suspected case of infant botulism, they will give your child a physical and neurological exam, which will likely include lab tests (typically a stool sample) as well.

From there, your baby will be given an intravenous antitoxin, which can neutralize the toxin in your baby's blood. This typically requires your child to be admitted to the hospital, where they could remain for days to weeks.

Of course, if you suspect your baby may be experiencing symptoms of infant botulism, you should contact your healthcare provider right away, as this article is not meant to be used as a substitution for medical advice.