Infant botulism linked to infant formula

OKLAHOMA CITY– The Oklahoma State Department of Health (OSDH) is urging parents and caregivers to be aware of a recall of ByHeart Whole Nutrition infant formula product, which have been linked to a botulism outbreak. 

There have been no cases of botulism connected to this outbreak reported so far in Oklahoma. Nationwide, as of Nov. 14, 2025, over 20 infants in 13 states are suspected or confirmed to have infant botulism after exposure to ByHeart infant formula.  

If you have purchased the recalled formula, follow the steps below: 

• Immediately stop use of any ByHeart Whole Nutrition infant formula.
  • This includes:
    • All lot numbers 
    • All sizes of cans and single-serve packets 
• If possible, take a picture or record the lot number and best-by date. 
• If you have leftover ByHeart powdered formula, label it “DO NOT USE” and keep it stored in a safe place for at least a month.
  • If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out. 
• Clean and sanitize any items and surfaces that may have come into contact with 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 develops any of these symptoms:
  • Poor feeding 
  • Loss of head control 
  • Difficulty swallowing 
  • Decreased facial expressions
• If this formula was used, it does not necessarily mean that symptoms will develop. However, due to the potential risk, we urge you to remain vigilant and monitor for any changes. 

Botulism is a rare but serious illness caused by a toxin, primarily by the bacterium Clostridium botulinum, that attacks the body’s nerves and causes difficulty breathing, muscle paralysis, and even death.  

If parents or caregivers have questions or concerns, they should contact their child’s health care provider. 

It is important to note that the recalled formula is not a WIC-eligible product.  

More information on the outbreak can be found at the links below: 

Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Botulism | CDC

Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA 

The Oklahoma State Department of Health (OSDH) protects and improves public health through its system of local health services and strategies focused on preventing disease. OSDH provides technical support and guidance to 68 county health departments in Oklahoma, as well as guidance and consultation to the two independent city-county health departments in Oklahoma City and Tulsa. Learn more at Oklahoma.gov/health. 

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