All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. 

November 11, 2025 - The FDA and CDC, in collaboration with CDPH IBTPP, and state and local partners, are investigating a multistate outbreak of infant botulism. Epidemiologic and laboratory data show that ByHeart Whole Nutrition infant formula might be contaminated with Clostridium botulinum, which is causing infant illness in multiple regions of the country.

Related: California Department of Public Health Announces Multistate Infant Botulism Outbreak Linked to ByHeart Infant Formula Sold Nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub.com and Others

As of November 10, 2025, a total of 15 infants with suspected or confirmed infant botulism and confirmed exposure to Byheart Whole Nutrition infant formula (various lots) have been reported from 12 states (see map). Laboratory confirmation for some cases is ongoing. For 14 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 10, 2025. All 15 infants were hospitalized. No deaths have been reported to date. For 14 infants with age and sex information available, they range in age from 16 to 157 days and 7 (50%) are female. 

State and local public health officials are interviewing caregivers about the foods the infants were fed in the month before they got sick. Fifteen infant botulism cases have been identified that were fed ByHeart Whole Nutrition powdered infant formula before getting sick. 

According to information shared by IBTPP, since August 1, 2025 through November 10, 2025, 84 infants nationwide have received treatment for infant botulism. Notably, more than 40% (15) infants who had powdered infant formula exposure consumed ByHeart Whole Nutrition infant formula.  This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States. Investigations remain ongoing but have not identified any other infant formula brands or shared exposures that pose a risk to infants.

As part of this investigation, officials in several states have collected leftover infant formula for testing. On November 8, 2025, preliminary laboratory results reported by the California Department of Public Health suggest the presence of the bacteria that produce botulinum toxin in a can of ByHeart infant formula (lot 206VABP/251131P2) that was fed to an infant with infant botulism.  Additional testing is underway, and results are expected in the coming weeks. Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product. 

FDA has been in contact with the firm and has requested a recall expansion to include all ByHeart infant formula on the market. On November 11, 2025, ByHeart expanded its recall to include all ByHeart formula nationwide, including cans and single-serve sticks. This advisory will be updated as additional information becomes available.

FDA’s investigation is ongoing to determine the point of contamination. This advisory will be updated as information becomes available.   

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Product:

All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. 

FDA is expanding its recommendation to include all ByHeart infant formula products due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).

ByHeart infant formula products makes up less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers. 
 

Symptoms of Infant botulism  

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, which can progress to difficulty breathing and respiratory arrest. Symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.

Stores affected

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.

Status

Ongoing

Recommendations

• Parents and Caregivers should stop using any ByHeart infant formula products immediately.
  • If your child consumed ByHeart formula and is experiencing symptoms (see below) seek immediate medical attention.
  • If your child consumed ByHeart formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
  • If you still have the formula in your home, you should:
    • take a photo or record the information on the bottom of the package.
    • keep the container in a safe spot and be sure to label that product as DO NOT USE.
    • 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.
• Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate medical attention. 
• If you are a Physician and suspect an infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.

 

Source: FDA