Infant Formula Company ByHeart Recalls ByHeart Whole Nutrition Infant Formula Due to Botulism Risk – Update

UPDATE (11/11/2025): All ByHeart Whole Nutrition Infant Formula products have been recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. You can view the update on the FDA’s website.

ByHeart, a baby nutrition company, is recalling all ByHeart Whole Nutrition Infant Formula products due to an outbreak of infant botulism. ByHeart formula is carried locally at Whole Foods and Target and is also available online. 

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants. It occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract of an infant. Affected infants may have some or all of the following symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

See the FDA’s website for product images at the bottom of the page.

What Consumers Should Do:

Consumers who have purchased ByHeart infant formula should immediately discontinue use and dispose of the product. Wash items and surfaces that may have touched the formula using hot soapy water or a dishwasher. Learn more on the CDC’s website.

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. To report an illness or adverse event, you can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

If any parents have questions they can contact Byheart at [email protected]. For more information, visit byheart.com or call 1(833) 429-4327 24/7.