On Tuesday, November 11, 2025, the California Department of Public Health (CDPH) issued a Health Advisory regarding a multi-state outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula. As of November 13, 2025, 15 infants with suspected or confirmed illness have been identified nationwide, including two here in California.
Because retailers in Santa Clara County received the recalled products, local families and health care providers may encounter concerns or questions about exposure.
What Has Been Recalled?
ByHeart Inc. has issued a nationwide recall of all their infant formula products, including:
-
Whole Nutrition Infant Formula (cans)
-
Anywhere Pack products
Families who purchased these items should stop using them immediately.
What Is Infant Botulism?
Infant botulism is rare but serious. It affects babies under 12 months old and can take several weeks for symptoms to appear. With early medical care and proper treatment, nearly all infants fully recover.
Possible Symptoms Include:
-
Trouble feeding
-
Difficulty swallowing
-
Constipation
-
Muscle weakness
-
Loss of head control
-
Flaccid paralysis
If your baby consumed ByHeart formula and shows any of these symptoms, seek medical care right away.
Guidance for Parents and Caregivers
If your child consumed ByHeart Whole Nutrition infant formula:
-
Stop using the product immediately.
-
Save the formula container, including any opened cans or packs.
-
Keep the lot number and expiration date.
-
Do NOT discard the product if your child has symptoms—Public Health may need it for testing.
-
If your baby remains symptom-free after a month, you may safely discard the remaining formula.
If symptoms appear, contact your child’s pediatrician right away and notify the County of Santa Clara Public Health Department.
Information for Medical Providers
The CDPH alert urges clinicians to:
-
Maintain a high index of suspicion for infant botulism.
-
Ask about ByHeart formula use in any symptomatic infant.
-
Consult immediately with the CDPH Infant Botulism Treatment and Prevention Program at (510) 231-7600 (available 24/7).
-
Begin BabyBIG® treatment promptly once clinical consultation supports a diagnosis—do not wait for lab confirmation.
-
Report all suspected cases immediately by phone to the County of Santa Clara Public Health Department’s
Communicable Disease Prevention & Control Program at (408) 885-4214.
FIRST 5 Santa Clara County will continue to share timely, trusted information to help keep children safe and healthy. If you support families with infants, please help spread this important update.
