ByHeart expands baby formula recall nationwide amid infant botulism outbreak. Here’s what parents should know

Credit: Target
ByHeart, a next-generation infant nutrition company, has expanded its voluntary recall to include all unexpired lots of its Whole Nutrition Infant Formula products.
Table of Contents
Every parent wants to trust what they feed their baby. You check the label, measure carefully, and rely on that familiar brand to keep your little one nourished and safe. So when a baby formula recall makes headlines, it’s only natural to feel uneasy.
ByHeart, a next-generation infant nutrition company, has expanded its voluntary recall to include all unexpired lots of its Whole Nutrition Infant Formula products, including cans and single-serve sticks, after the FDA and CDC linked the formula to multiple cases of infant botulism across 12 states.
Which ByHeart products are affected
The recall now includes all ByHeart Whole Nutrition Infant Formula products nationwide, including all unexpired cans and single-serve “anywhere” sticks.
The expansion comes after federal and state health officials identified additional cases of infant botulism and a preliminary positive sample for Clostridium botulinum in an open can of ByHeart formula.
Parents are advised to stop using all ByHeart infant formula immediately, take a photo or record the lot information, and label the product “DO NOT USE” in case it’s needed for testing.
Related: A popular baby bath tub sold on Amazon has been recalled for a hidden battery danger
What’s being investigated
As of November 10, 2025, 15 infants from 12 states have been reported with suspected or confirmed infant botulism after consuming ByHeart formula. All have been hospitalized, and no deaths have been reported. Illnesses began between August 9 and November 10, 2025.
Preliminary testing by the California Department of Public Health’s Infant Botulism Treatment and Prevention Program found the bacteria that produce botulinum toxin in one open can of ByHeart formula. Additional testing is underway.
The FDA and CDC are testing leftover formula to determine if it contains Clostridium botulinum, the bacteria responsible for infant botulism. Results are expected in the coming weeks.
Symptoms of infant Botulism to watch for
While infant botulism is rare, being aware of symptoms can help parents act quickly. Early signs may include:
- Constipation
- Poor feeding or weaker sucking
- Choking when trying to feed
- Eyelid drooping or lack of facial expression
- Weak or floppy muscles
- Reduced crying or energy
Symptoms may progress from early signs like constipation and poor feeding to loss of head control, difficulty swallowing, trouble breathing, or respiratory arrest.
If you notice any of these symptoms, seek medical care immediately. Early intervention can prevent complications. For more guidance, see the CDC Infant Botulism Resources.
What parents should do now
- Stop using all ByHeart formula immediately, regardless of lot number or expiration date.
- If your baby has consumed ByHeart formula and shows symptoms, seek medical attention immediately.
- If you’re a healthcare provider who suspects infant botulism, call 510-231-7600 for 24/7 consultation.
- Affected products should be safely discarded after 30 days if your infant shows no symptoms and the formula isn’t needed for testing.
- Stay observant: Monitor your baby for any symptoms listed above.
- Stay informed: Follow updates from the FDA and CDC, but know that less than 1% of infant formula nationwide is affected, so shortages are not expected.
Related: This Häagen-Dazs treat is under recall in 31 states—here’s what to know
Staying calm, staying safe
Being alert and informed is an act of love, not fear. By taking a moment to check your cans, watch for early symptoms, and follow guidance from trusted authorities, you’re protecting your baby while navigating a recall calmly and confidently. Informed parents help each other stay safe, and that’s exactly the community every caregiver needs.
Sources:
- U.S. Food & Drug Administration. 2025. “Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA”
- CDC. 2024. “Clinical Overview of Infant Botulism.”




















































































