What did FDA find during its inspection of ByHeart’s Allerton facility?

In February 2025, FDA conducted a routine inspection of our Allerton, Iowa facility and issued what’s called a Form 483. The observations focused on ingredient handling, pest-control protocols and documentation, and facility maintenance. For more context: The inspection cited company records showing that, in late 2024 and early 2025, certain ingredient shipments arrived from a third party with torn bags and signs of rodent activity that originated from an independent offsite warehouse. The affected materials were rejected at the time of observation, and remaining ingredients were inspected and verified before use. No adulterated product was used in production, and no consumer safety concerns were identified. Other observations of note were that one piece of equipment showed rust and flaking onto the floor and swabbed positive for Cronobacter, that was remediated in advance of FDA inspection, and the milk steel decking required full replacement. Both issues were addressed during a planned facility shutdown, with stainless steel replacements installed and maintenance completed.

What actions did ByHeart take after the February 2025 FDA inspection?

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.

Is the product recall related to the 2023 Warning Letter?

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.

ByHeart FAQs

Frequently Asked Questions

FAQs for Parents & Caregivers

Call our Parent Experience team at 866-201-9069 for all questions and concerns. 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.

No. Parents and Caregivers should immediately discontinue use of all ByHeart formula.

We cannot rule out the risk that all ByHeart formula across all product batches may 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.

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.

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 call us at 866-201-9069 and our team will assist you.

Once you speak to 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.

Yes, we recalled all affected batches immediately upon notification from FDA.

As soon as we learned the issue could be broader, we instituted a full recall of all products, regardless of batches. This came after a call with the FDA, informing us that they had found additional cases of infant botulism in babies that had consumed ByHeart at some point, following the broader outbreak notification on November 7. As part of our investigation, we immediately conducted a nationwide recall and began testing every batch of ByHeart formula to understand how Clostridium botulinum entered the food supply.

Yes. We continue to investigate the root cause, including 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 are working in cooperation with FDA to share results of our on-going investigation and to provide updates on our Safety and Education Hub 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 batches may have been contaminated.

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.

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.

Our decision to hold a Black Friday sale followed our approach last year and broader industry trends. We hoped to provide a wider window for parents to purchase infant formula, as formula is not an impulse purchase, and a month-long sale could offer more flexibility for parents.

ByHeart had no indication that our formula would be linked to an outbreak in infant botulism when we began planning for an initiated our Black Friday sale on November 3. Once we learned of the first recall involving two batches of formula on November 7, 2025, we immediately turned off all promotional and advertising content for that sale to prioritize the recall.

All purchases on ByHeart.com during that Black Friday sale are eligible for a full refund.

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.

In February 2025, FDA conducted a routine inspection of our Allerton, Iowa facility and issued what’s called a Form 483. The observations focused on ingredient handling, pest-control protocols and documentation, and facility maintenance.

For more context:

The inspection cited company records showing that, in late 2024 and early 2025, certain ingredient shipments arrived from a third party with torn bags and signs of rodent activity that originated from an independent offsite warehouse. The affected materials were rejected at the time of observation, and remaining ingredients were inspected and verified before use. No adulterated product was used in production, and no consumer safety concerns were identified.
Other observations of note were that one piece of equipment showed rust and flaking onto the floor and swabbed positive for Cronobacter, that was remediated in advance of FDA inspection, and the milk steel decking required full replacement. Both issues were addressed during a planned facility shutdown, with stainless steel replacements installed and maintenance completed.

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.

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