Infant Formula Recall Alert

The FDA and CDC, in collaboration with state and local health departments, and the California Infant Botulism Treatment and Prevention Program, are investigating a multistate outbreak of infant botulism. There have been at least 15 cases in 12 states, including 1 case in Arizona. There have been no deaths. As of 11/12/2025, there are no cases in Pinal County. This is a very fluid situation, so case counts may change frequently.

All of these cases have consumed ByHeart-brand powdered infant formula. Parents/Caregivers should not use any ByHeart Powdered Infant Formula. Please follow these instructions:

• Do not use recalled infant formula. Throw it away or return it to where it was purchased.
• If possible, record the lot number with a photo of the product & lot information.
• Wash 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 any of these symptoms and has consumed ByHeart Whole Nutrition Infant Formula:
  • Poor feeding
  • Loss of head control
  • Difficulty swallowing
  • Decreased facial expression

In some cases, symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if their infant consumed any powdered formula from ByHeart.

Please refer to the following website links for the most current information regarding this outbreak:

https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html

https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025

Additionally, this infant powdered formula is not distributed to WIC clients. However, if any WIC client has questions about this product or the outbreak, please contact the Pinal County Public Health Services District at 866-960-0633, and a WIC Team Member will address your questions.