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.

Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use and follow FDA guidance to:

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

Parents and Caregivers should immediately discontinue use of all ByHeart formula.

Based on the test results we have received as of November 19th, we cannot rule out the risk that all ByHeart formula across all product lots have been contaminated.

Parents and caregivers should monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.

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 time from ingestion to symptoms of infant botulism is estimated at 3 to 30 days. If you think your baby is experiencing symptoms of infant botulism, please contact your medical provider immediately.

Parents and Caregivers with concerns about this outbreak and infant botulism can also contact the California Department of Public Health hotline at 1-833-398-2022 (available Monday to Sunday from 7am to 11pm PST).

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 FDA.

The CDC recommends treatment with BabyBig (Botulism Immune Globulin Intravenous (Human)) based on clinical symptoms. 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. 

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.

We are recommending you sanitize any items or surfaces that may have come into contact with ByHeart formula. First, wash bottles, preparation equipment, countertops, and utensils using hot soapy water or run them through the dishwasher, followed by a disinfection step using sodium hypochlorite, peracetic acid or hydrogen peroxide. Next, leave this sanitizer on for a few minutes and thoroughly rinse with water.

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

Important Update

Our nationwide recall that we announced on Nov 11th includes all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Packs™. This action is being taken in close cooperation with U.S. Food and Drug Administration (FDA), Center for Disease Control (CDC) California Department of Public Health (CDPH) and other critical regulatory bodies.

Based on the test results we have received so far, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated. 

We urge parents and caregivers to stop using all ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.

Important Update

ByHeart is providing a full refund for all products purchased on ByHeart.com on or after August 1, 2025. This is a change to our previous policy, as we work to better support families during this time.

Although ByHeart was first notified on November 7, 2025, this refund approach is guided by the most complete data available from FDA identifying the first infant in the outbreak on August 9, 2025. 

Here are the key details:

• Customers are eligible for a full refund for all ByHeart.com purchases placed on or after August 1, 2025. 
• Please call us at 866-201-9069 and our team will assist you, 24/7. 

Once you speak to our team, you should expect to receive funds within 5-7 business days.

Important Update

As soon as we learned from FDA 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 unopened cans of ByHeart product, and conducted a nationwide recall.

We tested 36 samples from three lots and, as shared on November 19th, we received positive test results for Clostridium botulinum Type A in five of the 36 samples across all three lots. 

Based on these results we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated. 

We urge parents and caregivers to stop using all ByHeart formula immediately, monitor your child for symptoms of infant botulism, and seek medical care immediately if they develop symptoms.

We continue to be focused on finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples.

We have chosen this course of action because it will:

• More urgently and efficiently help identify root cause, which can help ByHeart and FDA better understand the scale of the contamination in ByHeart product, and provide more clarity for parents and caregivers in this uncertain moment
• Better serve FDA in their on-going investigation into the rise of cases of Infant Botulism, in case there is a shared ingredient or protocol across multiple infant formula or food products
• Help FDA and the medical community better understand how this specific pathogen entered the food supply in what is an unprecedented moment.

We will work in cooperation with FDA to share results of our on-going investigation and share updates on our Safety and Education Hub with answers to your questions and with any new information as soon as we learn more.

Based on the test results to date, we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated. 

We have redirected all of our resources toward finding the root cause, through a rigorous audit of every step of our product development chain, from suppliers and raw ingredients, through to packaging and transportation. This includes testing more product samples.

We have chosen this course of action because it will:

• More urgently and efficiently help identify root cause, which can help ByHeart and FDA better understand the scale of the contamination in ByHeart product, and provide more clarity for parents and caregivers in this uncertain moment
• Better serve FDA in their on-going investigation into the rise of cases of Infant Botulism, in case there is a shared ingredient or protocol across multiple infant formula or food products
• Help FDA and the medical community better understand how this specific pathogen entered the food supply in what is an unprecedented moment.

We will work in cooperation with FDA to share results of our on-going investigation and share updates on our Safety and Education Hub with answers to your questions and with any new information as soon as we learn more.

Important Update

On November 11, we conducted a full recall of all ByHeart cans and Anywhere Packs across ByHeart.com, Amazon and retailers nationwide. As part of our safety standards, and in alignment with regulatory requirements, we notified all retail partners to remove all ByHeart formula from their shelves. ByHeart has notified retailer partners multiple times, and they have confirmed communication has been sent to stores. FDA has also shared notifications with retailers.

Based on Consumer Product Recall Best Practices, there are safeguards in place to ensure that purchases of ByHeart infant formula cannot be completed if product is still on shelves and is scanned at the check out systems.

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 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 FDA.

We have been working with urgency and care since we first learned of the outbreak to implement the recall quickly and effectively. After FDA first 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 FDA of those findings and immediately informed our consumers. We are working to investigate the facts, conduct ongoing testing to identify the root cause, and ensure this does not happen to families again.

No. FDA issued warning letters to ByHeart, Reckitt and Perrigo and ByHeart’s published warning letter referenced an inspection of ByHeart’s Reading, PA plant that concluded in Feb 2023. 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 has not produced product for the market since 2023 and is not involved with production of the batches in the current recall.

For more information on the warning letter: On August 30, 2023, FDA issued warning letters to three infant formula manufacturers, ByHeart, Meade Johnson Nutrition (Reckitt) and Perrigo, as part of the agency’s ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible. These companies at the time manufactured the majority of the US-made infant formula brands that you would find on shelves. The published warning letter to ByHeart referenced an inspection of our Reading, PA plant that concluded in Feb 2023. Prior to the receipt of the warning letter, ByHeart had already submitted comprehensive responses to FDA’s observations from that inspection and there was no disruption to the manufacturing facilities or supply. No distributed ByHeart product at the time of the warning letter had tested positive for contaminants. FDA noted at that time, “The agency is not aware of any distributed product where contamination was confirmed”. FDA also noted that the agency “does not advise parents and caregivers to discard or avoid purchasing any particular infant formula at this time”. We commended FDA for its efforts to unify the industry’s ongoing work to elevate manufacturing and safety standards to protect babies. We also shared that we believe that the industry should embrace this level of transparency.

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 cooperating with 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.