ByHeart Recall Expanded to Include All Formula Ever Produced by the Company Due to Infant Botulism Risk

ByHeart expanded its refund policy in recent weeks due to customer backlash. Initially, the company offered refunds for only two units of product, whether that was two formula cans, two Anywhere stick packs, or one of each. However, the company is now offering refunds on all products purchased via byheart.com on or after Aug. 1, 2025. 

Still, there are some hoops to jump through: Customers who purchased formula from ByHeart’s website must contact the company directly to request a refund, and some customers reported they needed to provide a lot number before being issued a refund. 

Although the recall has now been expanded to include all products, families who purchased cans before Aug. 1 might not be eligible for a refund, according to ByHeart’s current refund policy. That means some families who subscribed to a several-month supply of formula could have cans on hand that are recalled and unusable, for which they cannot be refunded. Comments on the company’s Instagram account say that some consumers have been waiting weeks for the refunds to be processed, though the company website says refunds should be available five to seven days after speaking with a ByHeart team member.

If an infant swallows bacterial spores from Clostridium botulinum, the bacteria can multiply in their intestines and create a toxin that attacks the body’s nerves, according to the CDC. 

The spores can be naturally found in the environment, including in soil, dust, and some vegetables. Honey can also be a source of the spores that cause the botulism toxin, which is why infants under the age of 1 should not be fed honey.

The presence of C. botulinum is rare in infant formula, but it’s important to note that powdered infant formula is not considered to be sterile, unlike ready-to-feed formula. No matter how you feed your baby, experts recommend regularly sterilizing your feeding equipment, including bottles and nipples, as well as any formula dispensers, containers, cups, scoops, and mixers you may use. 

The FDA, the CDC, state public health departments, and ByHeart continue to test both opened and sealed cans of ByHeart formula for the presence of C. botulinum spores, and have found several positive samples across different lots and production dates, which is part of what led to the recall expansion. But false negatives can exist. “The detection of Clostridium botulinum in infant formula is complex, and a negative test result does not rule out the presence of the bacteria in the product,” the FDA says in a statement.

The FDA requires that formula makers test for cronobacter and salmonella species in the finished product, Rogers says, but not for the C. botulinum toxin. Most formula manufacturers do not currently test for the presence of C. botulinum spores as a regular practice, and the spores can be difficult to detect. Bobbie, another formula maker, recently announced that it would start to test their formula for sulfite-reducing clostridia (SRC), a screening used to identify potential spore-forming bacteria, including C. botulinum, the company says. A positive result would indicate the need for further testing.

Here are the steps to take first.

• If your baby has been fed with ByHeart formula, it’s important to switch your baby’s formula to another brand right away and to watch for signs of infant botulism in your baby. 
• Write down or photograph the lot numbers of any ByHeart formula you have and store it securely for 30 days, or check with your local health department before disposing of it. You can contact the company at hello@byheart.com for information, or call 833-429-4327.
• If you have recalled formula, wash all items and surfaces in hot soapy water or in a dishwasher, the CDC says. Consider throwing out any bottles or feeding items that may have come into contact with the formula.
• If you have specific questions about your baby’s formula or nutrition, your pediatrician is your best resource. 
• For questions about the botulism outbreak, you can contact the California Department of Public Health’s public hotline at 833-398-2022. 
• To report an illness, contact your state’s local health department, fill out the FDA’s MedWatch Online Voluntary Reporting Form, or call an FDA Consumer Complaint coordinator.