For immediate release: November 10, 2025                                           (25-135)

Contact: DOH Communications

Infant formula recalled because of possible link to infant botulism cases 

Ten states are involved, one of the 13 affected infants is from Washington 

OLYMPIA – The Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the Washington State Department of Health (DOH), and officials in nine other states are investigating an outbreak of botulism linked to powdered infant formula produced by ByHeart. 

Thirteen infants in 10 states have been involved in the outbreak, including one infant from Lewis County in Washington state. All cases included in this outbreak are reported to have consumed ByHeart brand powdered infant formula. ByHeart has voluntarily recalled the formula.   

If you have recently purchased a ByHeart Whole Nutrition Infant Formula: 

• Do not use. Throw it away or return it to where you bought it. If you still have the container, record the lot number before discarding. 

• Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher. 

• Seek immediate medical care if your infant has consumed ByHeart Whole Nutrition Infant Formula and has any of these symptoms: 
  
  
• Poor feeding 
• Loss of head control 
• Difficulty swallowing 
• Decreased facial expression

Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used the recalled lots of infant formula. 

Infant botulism is a rare illness that usually affects babies less than six months of age. Babies get ill when bacteria (Clostridium botulinum) they have ingested produce a toxin that can weaken muscles. These bacteria are naturally found in dust, soil and honey (which should never be given to babies under a year). It is rare for a commercial infant food product to be linked to an outbreak of infant botulism.  

This is an active investigation. For the most current updates, please see the CDC Food Safety Alert and FDA Outbreak Investigation of Infant Botulism. 

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