Call our Parent Experience team at 866-201-9069 for all questions and concerns. We’re available 24/7. You can speak with a person live, or leave your number and we’ll call you back as soon as possible.

Please immediately discontinue use and dispose of all ByHeart formula. The results of third-party testing have confirmed the presence of Clostridium botulinum in samples of ByHeart formula.

Infant botulism is the infectious form of botulism, which results when swallowed spores of a particular bacterium (Clostridium botulinum) colonize the baby's large intestine and produce botulinum toxin.

According to the American Academy of Pediatrics (AAP), in infants, the illness often begins with constipation followed by difficulty feeding (sucking and swallowing), a weak and altered cry, diminished facial expression, droopy eyelids, loss of head control, and lethargy. The incubation period for infant botulism can range from 3-30 days. If you think your baby is experiencing symptoms of infant botulism, please contact your medical 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.

Infant botulism is treated with a combination of supportive care and a medication called an antitoxin. Please reach out to your medical provider immediately if you suspect your baby is experiencing symptoms of infant botulism.

No, the Infant Botulism Treatment and Prevention Program reports there are typically no long-term effects from infant botulism. As long as there are no serious complications during the hospital stay, babies generally make a full and complete recovery, with no lasting health problems.

Out of an abundance of caution, we are recommending you sanitize any items or surfaces that may have come into contact with ByHeart formula. Wash bottles, preparation equipment, countertops, and utensils using hot soapy water or run them through the dishwasher.

For device/appliance specific use or cleaning instructions, such as Baby Brezza, contact the original manufacturer for guidance.

Our nationwide recall includes all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs™. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), Center for Disease Control (CDC) California Department of Public Health (CDPH) and other critical regulatory bodies.

The investigation remains ongoing. Parents and Caregivers should immediately discontinue use and dispose of all ByHeart formula at this time.

Parents and caregivers who have purchased ByHeart Whole Nutrition Infant Formula, including cans and Anywhere Packs, should immediately discontinue use of the product. 

If your child develops symptoms, your state health department might want to collect your formula container for testing. Keep the container in a safe spot and be sure to label that product as DO NOT USE. If your child does not develop symptoms after 30 days, throw your containers out. 

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.

Orders placed on ByHeart.com on or after October 1, 2025 will be eligible to receive a refund. Please call us at 866-201-9069 and our team will assist you. We’re available 24/7.

• Customers will receive a refund of up to two units of ByHeart product—cans or Anywhere Packs. 
• First-time customers will receive a full refund on their first order, staying true to our ByHeart Promise.

If you purchased ByHeart through one of our retail partners or Amazon, please contact the retailer directly and they will assist you with your refund options. 

After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test cans of ByHeart formula, and conducted a nationwide recall. Those results identified Clostridium botulinum in some samples of unopened ByHeart formula.

Our investigation remains ongoing. We immediately notified the FDA of the findings of our independent third-party testing, and we are working to investigate the facts, conduct ongoing testing to identify the root cause, and ensure this does not happen to families again.  

We have been working in cooperation with the FDA, and we are investigating every facet of our process – from ingredient-sourcing, to our manufacturing process and facilities, our packaging, our transportation, everything. 

We will continue to update our Safety and Education Hub with answers to your questions and with any new information as soon as we learn more.

After the FDA informed us of the infant botulism outbreak on November 7, we immediately partnered with IEH Laboratories & Consulting Group, a global leader in Food Safety testing, to test cans of ByHeart formula, and conducted a nationwide recall. We learned that those tests identified Clostridium botulinum in some samples of ByHeart formula, and immediately notified the FDA of those findings. We are working to investigate the facts, conduct ongoing testing to identify the root cause, and ensure this does not happen to families again.

There was a warning letter in 2023 of issues at the Reading, PA plant. ByHeart undertook action to address the issues and there are no open issues from that warning letter. The batches in the current recall were produced at ByHeart's plant in Allerton, IA and canned at ByHeart's Portland, OR plant. ByHeart's facility in Reading, PA is not involved with production of the batches in the current recall.

We do not yet know the root cause, but we are committed to finding the answers. We are doing everything we can to ensure this investigation reveals solutions and aids in understanding cases of infant botulism broadly. That’s what parents, the medical community, and you deserve.

We are working with the FDA to understand how Clostridium botulinum entered the food supply and to be part of the solution by advancing testing standards and safeguards to ensure the highest level of safety for families.