Frequently Asked Questions
FAQs for Parents & Caregivers
You can reach our Parent Experience team at hello@byheart.com. Our team is happy to assist you.
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.
No. Parents and caregivers should immediately discontinue use of all 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 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.
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.
Please reach out to your medical provider immediately if you suspect your baby is experiencing symptoms of infant botulism.
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 the 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.
Recall FAQs
Yes. The nationwide recall that we announced on Nov. 11 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.
We cannot rule out the risk that all ByHeart formula across all product batches 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.
Yes. ByHeart is providing a full refund for all products purchased on ByHeart.com on or after August 1, 2025. This refund policy has been extended to August 1, 2025, following FDA’s identification of the first infant in the outbreak on August 9, 2025.
Please email us at hello@byheart.com and our team will assist you.
Once you connect with our team, you should expect to receive funds within 5-7 business days.
For customers who purchased ByHeart products at Retail stores, that retailer will handle your refund. We encourage you to contact them directly for details about their refund policy and to process your refund for ByHeart infant formula.
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, seek immediate medical attention.
If your child does not develop symptoms after 30 days, throw your containers out.
As part of our safety standards, and in alignment with regulatory requirements, we have notified all retail partners to remove all ByHeart formula from their shelves. After the initial two-batch recall on November 8, 2025, ByHeart notified retailer partners multiple times, and we have confirmed communication has been sent to stores. FDA also shared notifications with retailers.
According to its latest update, FDA has not received reports of recalled formula being found on store shelves since November 26, 2025.
Regulatory FAQs
Under Food Safety Modernization Act (FSMA) requirements, each of our three facilities is inspected at least once annually, and FDA also can perform additional unannounced inspections. These inspections are a core part of ByHeart’s continuous improvement program.
FDA’s policies specify that FDA should publish certain records if the agency has received frequent Freedom of Information Act (FOIA) requests for those records, which may have happened because of public and media interest in the botulism outbreak.
Under ByHeart’s ownership, our three facilities have been inspected a total of seven times by FDA while in production. One additional inspection occurred when our Reading, PA facility was non-operational.
Of the seven inspections, five received the FDA designation of NAI, or “No Action Indicated,” meaning that the inspection didn’t reveal any violations and FDA determined no additional agency action was appropriate.
The February 2025 inspection for Allerton, IA, received a designation of VAI, or “Voluntary Action Indicated,” which means that FDA concluded its observations could be addressed through voluntary improvements without the need for any additional regulatory action. All observations were addressed promptly, and several were identified internally as part of our monitoring and improvement processes and corrective actions were already in progress before FDA review.
The February 2023 inspection for Reading, PA received a designation of OAI, or “Official Action Indicated.” In August 2023 Warning Letters were issued to multiple infant formula manufacturers and the Warning Letter issued to ByHeart referenced this inspection.
ByHeart has since addressed all issues from the 2023 Reading inspection and corresponding Warning Letter.
The January 2024 inspection for Reading occurred while the facility was under-going planned upgrades and was non-operational.
Under Food Safety Modernization Act (FSMA) requirements, each of our three facilities is inspected at least once annually, and FDA also can perform additional unannounced inspections. These inspections are a core part of ByHeart’s continuous improvement program.
FDA’s policies specify that FDA should publish certain records if the agency has received frequent Freedom of Information Act (FOIA) requests for those records, which may have happened because of public and media interest in the botulism outbreak.
Under ByHeart’s ownership, our three facilities have been inspected a total of seven times by FDA while in production. One additional inspection occurred when our Reading, PA facility was non-operational.
Of the seven inspections, five received the FDA designation of NAI, or “No Action Indicated,” meaning that the inspection didn’t reveal any violations and FDA determined no additional agency action was appropriate.
The February 2025 inspection for Allerton, IA, received a designation of VAI, or “Voluntary Action Indicated,” which means that FDA concluded its observations could be addressed through voluntary improvements without the need for any additional regulatory action. All observations were addressed promptly, and several were identified internally as part of our monitoring and improvement processes and corrective actions were already in progress before FDA review.
The February 2023 inspection for Reading, PA received a designation of OAI, or “Official Action Indicated.” In August 2023 Warning Letters were issued to multiple infant formula manufacturers and the Warning Letter issued to ByHeart referenced this inspection.
ByHeart has since addressed all issues from the 2023 Reading inspection and corresponding Warning Letter.
The January 2024 inspection for Reading occurred while the facility was under-going planned upgrades and was non-operational.
ByHeart took immediate actions, which were all completed and verified to FDA by October 2025:
- Engaged two independent pest-control experts to inspect and verify the entire site.
- Replaced wall insulation, flooring, and certain equipment with stainless-steel upgrades.
- Strengthened ingredient inspection, risk-assessment, and documentation procedures.
- The company submitted six updates to FDA between March and October 2025, and all corrective actions were completed and verified by October 31, 2025. ByHeart’s swift response shows its safety systems worked: issues were identified, corrected, and independently confirmed.
As of now, we have not identified any links between those earlier findings and the November 2025 recall. Our investigation into the root cause of the recall is still ongoing, and the company is committed to ensuring we fully understand what led to our formula products being contaminated.
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, Mead 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.
Investigation FAQs
ByHeart is working toward the safe resumption of infant formula production, in close cooperation with the FDA.
We don't have a specific timeframe to share yet. Returning to market is something we're working toward, but we won't resume production or sales until we're confident our safety protocols meet the standards we hold ourselves to.
The FDA has concluded its inspection of ByHeart's facilities and identified no deficiencies that could explain the root cause of the outbreak.
FDA is continuing its work focused on ingredients, including the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified. We do not have an anticipated timeline for the conclusion of that investigation, but we continue to offer our full cooperation.
As part of our Action Plan, we are prioritizing developing and implementing new testing protocols.
We worked with a reputable third-party lab partner to develop a new Clostridium botulinum-specific testing protocol with heightened sensitivity to previously used protocols that will be applied to every dairy ingredient and to finished batches before they are released from our facilities. We will share more on this soon.
FDA has concluded its facility inspections, and shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.FDA is continuing its investigation into ingredients, including the powdered milk ingredient produced by a third party supplier where Clostridium botulinum was identified.
FDA has shared their lab analysis and found genetic matches involving two positive samples of C. botulinum Type A: the first is a sample of ByHeart infant formula, and the second is a sample of whole milk powder collected by FDA from a supplier to ByHeart.
These findings are consistent with the whole genome sequencing (WGS) analysis conducted by ByHeart at IEH Laboratories, representing a concrete genetic match between the whole milk powder ingredient, finished ByHeart formula, and a clinical sample from a child with infant botulism from this outbreak.
We continue to offer our full cooperation as their investigation into ingredients continues.
Testing for C. botulinum is not the industry standard. Instead, the industry relies on preventive controls, validated processing steps, and an indicator test to identify SRC (sulphite-reducing Clostridia) to ensure stricter supplier selection and qualification.
Our testing on the whole milk powder we received from suppliers met those industry and regulatory standards. This outbreak has made clear that those existing safeguards are not sufficient, and that this pathogen can make its way into the infant formula supply chain.
In developing our Action Plan, we have worked with a reputable third-party lab partner to develop a new Clostridium botulinum-specific testing protocol with heightened sensitivity to previously used protocols that will be applied to every dairy ingredient and to finished batches before they are released from our facilities.
We will share further details as these are finalized.
All ByHeart suppliers must meet rigorous approval criteria designed to ensure the highest standards of safety, quality, compliance, and transparency.
The process begins with supplier pre-screenings, including evaluation of the company’s relevant certifications (such as SQF, BRCGS, or ISO), regulatory compliance, and alignment with ByHeart’s strict quality and food safety standards.
Qualified suppliers then undergo a comprehensive audit, including but not limited to a detailed review of pre-requisite programs, standard operating procedures, food safety and allergen control plans, environmental monitoring programs, heavy metal and contaminant testing policies, and detailed product specifications and certificates of analysis covering origin, analytical testing, and microbiological testing.
Suppliers are also assessed on sustainability and traceability practices, including ESG programs, and are classified through a detailed risk assessment.
ByHeart also conducts regular onsite or virtual audits to verify program execution, identify gaps requiring corrective actions and to ensure continued adherence to ByHeart’s stringent requirements.
ByHeart has extensive supplier specification in place covering dairy ingredients. This includes stringent specifications that cover pathogens (B. cereus, Staphylococcus, E. coli and Salmonella), spores (total spore count & SRC), and hygiene indicators (Enterobacteriaceae and coliforms).
We hold our ingredients to stringent limits for each specification.
ByHeart ensures ingredients are not contaminated after arrival through multi-layered controls designed specifically for infant safety.
Upon arrival at our production sites, shipments undergo strict security checks and anything of concern is immediately quarantined.
Ingredients remain on hold while documentation, such as Certificates of Analysis, lot codes, and specifications, are verified, packaging and labeling are inspected, and third-party laboratory testing is completed for identity, nutrients, and microbiological safety.
Once reviewed and approved by our Quality team, ingredients are stored under controlled environmental conditions, and they are further protected by validated sanitation programs, environmental monitoring, foreign material controls, and full lot-level traceability throughout manufacturing and packaging.
Yes. ByHeart maintains a robust Supplier Approval Program (SAP) aligned with FDA requirements and industry best practices.
The Supplier Approval Program is a process used to assess, approve, and continually monitor their ingredient, packaging, and service suppliers to ensure they meet safety, quality, and regulatory requirements.
This ensures all suppliers providing goods or services meet both regulatory standards and ByHeart’s standards for quality, safety, compliance, reliability, consistency and ethical practices before entering into or continuing a business relationship.
This framework is designed to mitigate risk, protect consumers, and support consistent operational excellence.
Even though testing on the organic grass-fed whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient. This outbreak revealed that this pathogen can make its way into the infant formula supply chain. Going forward, we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain.
To complement this enhanced testing, we are developing a comprehensive set of additional preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C.botulinium or other spore-forming bacteria. We will share further details as these are finalized.
At this time, we are not naming specific suppliers we work with. We do not have visibility into who else they may be working with outside of ByHeart.
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