The California Department of Public Health (CDPH), in collaboration with the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA), has issued an urgent health advisory regarding a nationwide recall of ByHeart Whole Nutrition Infant Formula. This action follows an unprecedented multi-state outbreak of infant botulism linked to the powdered formula.
What Happened?
As of November 11, 2025, 15 infants across 12 states have been hospitalized with suspected or confirmed cases of infant botulism. The affected states include California, Arizona, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. All infants were between 2 weeks and 5 months old, and all had consumed ByHeart formula. Fortunately, no deaths have been reported so far.
The outbreak began in August 2025, and preliminary testing by CDPH detected Clostridium botulinum type A spores in a sample of ByHeart powdered formula. This bacterium produces a neurotoxin that can cause severe illness in infants, including paralysis if untreated.
Recall Details
- Initial Recall (Nov. 8): Two lots were recalled:
- Lot 206VABP/251261P2 (Use by Dec 1, 2026)
- Lot 206VABP/251131P2 (Use by Dec 1, 2026)
- Expanded Recall (Nov. 11): All ByHeart Whole Nutrition Infant Formula products nationwide, including cans and single-serve Anywhere Pack™ sticks.
ByHeart products were sold online and at major retailers such as Amazon, Target, Walmart, Whole Foods, and Kroger. The FDA emphasized that ByHeart accounts for less than 1% of U.S. formula sales, so this recall will not cause a nationwide shortage.
Why Is This Serious?
Infant botulism is rare but dangerous. Symptoms can take weeks to appear and may include:
- Constipation
- Poor feeding
- Drooping eyelids
- Loss of head control
- Weak cry
- Breathing difficulties
If untreated, botulism can lead to paralysis and even death. All affected infants received BabyBIG®, the only treatment for infant botulism, which is produced by California’s Infant Botulism Treatment and Prevention Program.
What Should Parents Do?
- Stop using ByHeart formula immediately.
- Record the lot number and expiration date.
- If your baby consumed the formula, monitor for symptoms for up to 30 days.
- If symptoms appear, seek emergency care and keep the formula for testing.
- Wash and sanitize any surfaces or utensils that came into contact with the formula. [cdc.gov]
For more information, contact:
- ByHeart Customer Support: hello@byheart.com or (833) 429-4327
- CDPH Infant Botulism Program: (510) 231-7600 (24/7). [cdph.ca.gov]
The Bigger Picture
This recall is unusual because no unopened cans have tested positive for contamination so far. Investigators are still determining the source of the spores. ByHeart has pledged full cooperation with the FDA and CDPH and is conducting independent testing of all batches.
Key Takeaways
- All ByHeart formula products are under recall.
- Infant botulism is rare but life-threatening.
- Parents should act immediately to protect their children
Recommendations
- Maintain a high index suspicion for infant botulism and ask parents about the use of ByHeart Whole Nutrition infant formula in any suspected cases
- Parents of children with suspected infant botulism are encouraged to retain opened containers and save lot numbers and expiration dates of any infant formula consumed by the child and report to their local health department.
- If infant botulism is suspected, consult with experts at the CDPH Infant Botulism Treatment and Prevention Program immediately at 510-231-7600. Consultation is available 24/7.
- If clinical consultation supports a diagnosis of infant botulism, begin treatment with BabyBIG® as soon as possible. Do not wait for laboratory confirmation.
- Infant botulism is a notifiable disease. All suspected cases must be reported immediately by telephone to the local health department of the patient’s residence.