Recent Increase in Infant Botulism Likely Linked to Infant Formula

The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program are investigating a multistate outbreak of 15 infant botulism cases, including two in Texas. Nationally, 84 cases of infant botulism have been reported since August 2025.

Infant botulism is an illness caused by ingesting Clostridium botulinum spores or toxins that attack the nervous system.

Mary Suzanne Whitworth, M.D., medical director of Infectious Diseases at Cook Children’s, explains that infant formula has not been shown to cause infant botulism previously, noting this is the first time.

“Preliminary testing reveals the possible identification of Clostridium botulinum in one of the cans of formula, with confirmation still pending,” said Dr. Whitworth.

The CDPH Infant Botulism Treatment and Prevention Program (IBTPP) reported an increase in botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 15 cases included in this outbreak are reported to have consumed ByHeart brand powdered infant formula.

The FDA notified ByHeart on Nov. 7, and the company announced Tuesday, Nov. 11, a voluntary recall of all ByHeart Whole Nutrition Infant Formula and single-serve Anywhere Pack™ sticks.

Product Details for Voluntary Recall:

Can UPC: 85004496800

Anywhere Pack™ UPC: 85004496802

Product Image:

Photos courtesy of FDA

What Consumers Should Do:

Impacted consumers should immediately discontinue use and dispose of the product. 

Botulism is uncommon in dairy products or infant formula and is naturally occurring in environmental sources such as soil, select vegetables, and dust. The ByHeart brand of formula accounts for 1% of formula in the United States and the recall is not expected to result in a general formula shortage.

Officials in several states have collected leftover infant formula for testing. The testing is underway, and results are not yet available, but are expected in the coming weeks.  

What are the symptoms of botulism?

Symptoms of infant botulism can take as long as several weeks to develop following formula ingestion.

• Constipation
• Change in facial expression
• Ptosis
• Loss of head control
• Difficulty swallowing, poor feeding
• Generalized weakness
• In severe cases, respiratory failure

If your infant exhibits any symptoms or you are concerned they may have been exposed to the recalled formula, call your pediatrician.  If the child has difficulty breathing or severe weakness, they should call 911 or proceed to the nearest emergency department.