Let the Botulism Babies and Parents speak for themselves

Tomorrow I will be speaking up on Capitol Hill about what can be done to make infant formula safer in the US and around the world. My hope is that Congress, the FDA and the President will listen, not just to me and science, but to understand the reason why the work is so necessary. Here are just 11 of the 51 reasons:

Baby 1: When our six-month-old son was diagnosed with infant botulism, our world stopped. Watching our baby, who should have been learning, growing, and thriving – was suddenly facing a life-threatening condition, which is something no parent is prepared for. In the span of three days, our healthy baby boy exhibited failure to thrive, as he lost function of his motor skills, was unable to swallow, and his digestive tract was impacted. The fear and helplessness of seeing our child suffer and not knowing if he would recover or what long-term effects such as paralysis, respiratory issues, or even death that he might face, is a trauma that will stay with us forever.

What makes this experience even harder to accept is knowing it may have been prevented. Families should not have to endure this kind of trauma due to preventable risks or corporate negligence. Companies must be held accountable for their role in protecting the health and safety of the most vulnerable, especially infants who have no voice of their own. 

We believe it is critical that Congress understands the real human cost behind cases like ours. We urge Congress to recognize these failures and to hold companies fully accountable for their role in protecting infants and families. Strong action can spare other families from enduring the fear, heartbreak, and lasting trauma that ours has endured. No parent should ever have to watch their child fight for their life because of failures that could have been avoided.

Baby 2: “It’s been a nightmare.” That’s what I find myself saying to friends and acquaintances after sharing the story of what happened to my son over the last three months. What began as a slow, but noticeable weight loss and decreased feeds in late October quickly spiraled into a lengthy hospitalization with multiple readmissions for various setbacks and complications. Silent aspiration, oxygen levels in the low 80s, inability to feed from a bottle normally, the inability to hold his head up, and the inability to breath without oxygen. These are some of the complications he encountered. 

The darkest day was the day he got air-flighted from Flagstaff to Phoenix Children’s Hospital. That’s when the realization hit that my previously perfect baby was very seriously ill. It was just two days after that when they told us our son had had three small strokes in the back of his brain. After finally getting treated with Baby BIG, the antitoxin for infant Botulism, we noticed dramatic improvements in our son’s ability to hold his head up within just 2-3 days. We are thankful for this life-saving treatment. I understand the cost of Baby BIG is just over $69,000 for one dose. I can’t help but wonder how different our lives would be, how different Kohen’s life would be, if manufacturers were required to screen for microorganisms like Botulism and Cronobacter. The cost of screening is surely less than the antitoxin for Botulism, and with Botulism diagnoses on the rise something needs to be done to prevent another family from going through what we’ve endured. I didn’t realize when I chose to stop breastfeeding at two months postpartum that my research of formulas should include whether or not companies voluntarily screen for these microorganisms. 

The ripple effect of the has affected not just our son, but also his parents, his brother, his grandparents, aunts, uncle, friends and neighbors. It’s taken an entire community who rallied together to get us to the place we are in today, which is a place of uncertainty, but also hope. He is still fed through an NG tube and any formula he eats by mouth has to be thickened so he doesn’t aspirate it into his lungs. We are hopeful he will make a full recovery in time, but I still mourn all that’s been lost in our new baby experience from this  illness. 

Baby 3: As for a statement, this experience was the hardest thing my wife and I have ever been through. Our daughter changed so much overnight and kept getting worse.  She had no energy, could barely move or open her eyes, couldn’t hold her head up or eat or drink. We had to take her to the hospital 4 times before someone suspected botulism. We didn’t know if she was going to survive. 

She was in the hospital for 3 weeks but has required many follow up visits with her doctor and other specialists. She still hasn’t fully recovered and will require more visits with doctors and physical therapists to get her development back on track. My wife and I have had to take a lot of time off from work and this situation has had a tremendous effect on our mental and emotional state. We will do whatever we have to in order for our daughter to recover, but it hasn’t been easy. 

Baby 4: I am one of the many parents directly impacted by the ByHeart infant formula botulism contamination. As a parent, nothing prepares you for the fear and helplessness of realizing that something meant to nourish and protect your baby would instead cause them harm. This experience shattered our sense of safety at one of the most vulnerable moments in our lives, when our only focus should have been our child’s healthy growth and development.

Like many families, we chose ByHeart because of the trust it cultivated—positioning itself as a transparent, science-backed, and parent-first brand. We relied on this formula as our baby’s primary source of nutrition, believing it met the highest safety and quality standards; that trust was not given lightly. We depend on companies and regulators to ensure that what reaches store shelves is unquestionably safe. When that trust is broken, the consequences are not just emotional—they were physical and long-lasting.

This crisis underscores the urgent need for stronger oversight and a faster, more proactive FDA response to contamination risks in infant formula production. We urge Congress to ensure the FDA is empowered with the resources, authority, and accountability measures necessary to prevent failures like this from happening again. No parent should ever have to question whether feeding their baby could put their child’s life at risk.

Baby 5: This experience has changed our lives. 

From feeling disgusted in myself when I eat; seeing that my son cannot enjoy a meal with me, and from having to be his life support and watch him relearn communication; I’m convinced at times that I am incompetent. 

My son’s strength gives me motivation to fight and speak up for him. 

I never thought being so proud to be a mother ; would come with my baby meeting fear at a defenseless age . 

I have faith in all who goal to correct this situation.

No matter the mountain I’m going to climb it for my son, and I appreciate you for hearing our voices. 

Baby 6: We want to share our experience and the profound mental and emotional hardship our family has endured following our two-month-old infant’s diagnosis with botulism. This experience has been deeply traumatic, and it has permanently altered what should have been a time of bonding, joy, and learning to care for our first child. We are grateful that this situation is now being thoroughly investigated and given the serious attention it deserves, so that stronger safety measures can be put in place to prevent other families from enduring the same ordeal.

It is devastating when new parents—already navigating the vulnerability and uncertainty of caring for a newborn—are forced to confront a life-threatening illness that was both unnecessary and preventable. From the earliest weeks, we knew something was wrong. For several weeks prior to her diagnosis, we repeatedly sought medical guidance to address significant feeding challenges. More than half of each bottle would drain from her mouth, leaving us fearful that she was not receiving the nutrition she desperately needed. In response, we fed her nearly twice the recommended amount, increased the frequency of feedings, and woke her throughout the night to ensure she was getting enough nourishment.

Despite our constant vigilance and growing concern, we had no explanation for her worsening condition. Watching our newborn slowly deteriorate—without answers—was emotionally unbearable. The fear, self-doubt, and helplessness we experienced during this time are difficult to put into words. It was not until we received an automated call from the retailer where we purchased ByHeart infant formula that we finally began to understand the cause of what our child was suffering.

Seeing our two-month-old baby connected to feeding tubes and vital monitors was one of the most heartbreaking and traumatizing moments of our lives. The emotional toll of witnessing her in that state, combined with extreme sleep deprivation, overwhelming stress, lost work, and ongoing medical and recovery appointments, has had a lasting impact on our mental health and our family’s well-being.

We sincerely hope no other family ever has to experience this kind of fear and trauma during what should be the most precious and formative time of their child’s life. We are thankful that this incident is receiving the attention necessary to address and correct critical safety testing deficiencies, and we pray that meaningful changes are made to ensure the safety of infants and peace of mind for parents everywhere.

Baby 7: Our son was hospitalized with infant botulism after consuming powdered infant formula—something we gave him believing it was safe and carefully regulated. In a matter of days, a healthy baby lost the ability to eat, move, and function normally. No parent should ever have to watch their child suffer this way from a product specifically designed for infants. This should not have happened, and the fact that it did points to serious failures that must be addressed.

What is often missing from policy discussions is the human reality behind these cases. We are not data points or rare anomalies—we are families whose lives have been permanently altered. The emotional trauma, financial strain, and long-term uncertainty do not end when a hospital stay ends. Action is urgent because babies are still being born, parents are still relying on these products, and families should not have to wait for another child to be harmed before safeguards are strengthened. Accountability and meaningful change are necessary to ensure infant safety is truly non-negotiable.

Baby 8: We believe companies can correct mistakes only when there is real accountability. In this case, warnings about potential contamination were ignored, and infant safety failed. If there isn’t real regulatory change that comes from this, the message to the industry will be that the risk to babies’ lives can simply be priced in as a cost of doing business. We’re asking Congress to put child safety ahead of profit and ensure this never happens again.

Baby 9: I want to be able to share my perspective and take as my daughter’s mom, since she is unable to advocate for herself as she is only 9 months old. She was 6 months old when she was treated for Infant Botulism at Rady’s Children Hospital in San Diego CA. As a working mom, and some who was struggling to produce milk to feed my daughter, I trusted and used the Byheart formula for only 5 weeks. It is crazy how those 5 weeks were so impactful on our daughter, and how I saw the light and spirit of her change. I had no idea what was happening to her, only knowing something was not right, as my daughter who was always a happy, outgoing, smiley baby with no health issues, was fading and changing that last two weeks before we were aware that out daughter was impacted and needed treatment for Infant Botulism.

As parents, this experience has been absolutely heartbreaking and something we will carry with us forever. We have always been extremely cautious about what we put in her body and what we expose her to from the food she eats to the clothing she wears and the toys she plays with. We carefully research products and make decisions with her safety and well-being at the forefront. We truly believed we were making the best possible choice for our child when we purchased what we thought was a high-quality, safe, and trustworthy formula. It is devastating to know that what we believed was the best choice for her turned out to be anything but.

During her illness, we watched our daughter change in ways that were terrifying and deeply distressing. Her face became frozen, her expression disappeared, and tears would roll down her face while she was unable to cry out for help, her body was weak, and she wasn’t being active and strong like she normally was. At the time, we did not fully understand that paralysis was slowly spreading through her body. Not knowing what was happening, how much she was suffering, or how far the paralysis might progress is something no parent should ever experience. As a school psychologist, I worry what this impact may have on her long term social emotional well-being. 

She lost abilities she had already developed her ability to vocalize, to cry, and to control her muscles. She could not communicate her needs or discomfort, and as her parents, we were left helpless, watching our child struggle without being able to comfort her or understand what she was feeling. We now know that had she not received medical care when she did, we could have lost our child. Even with treatment, the risk of severe and lasting long-term impacts was very real.

After treatment, her recovery was not immediate. It took significant time for her mouth and feeding abilities to improve, and while there has been progress, we continue to live with uncertainty about the long-term effects. She now struggles with ongoing gastrointestinal issues and severe constipation that requires daily medication. Because she is still so young, she cannot tell us what she feels, if she is uncomfortable, or if something is wrong, and that uncertainty is incredibly painful as a parent.

This experience has changed our family forever. The fear, the helplessness, and the lasting uncertainty are things no family should have to endure. Our hope in sharing her story is that no other child or family has to go through this. If changes can be made to prevent this from happening again, then sharing our pain and experience may help protect other children and families from enduring the same trauma.

Baby 10: I researched the ByHeart formula after being told I needed to start supplementing my baby’s feeds due to him losing weight. I initially chose ByHeart due to it being labeled as organic, whole milk from grass-fed cows, close to breast milk, being awarded the Clean Label Project Purity award, made by us in the US with globally-sourced ingredients, and being clinically tested. I started feeding my baby ByHeart formula on September 18th of 2025. My baby first started to show signs of Infant Botulism on October 19th of 2025, while we were attending church. He began to be unable to support his neck and started to have a decrease in his appetite.

My baby’s symptoms started to increase while in the middle of moving from Washington state to Tennessee. When we arrived in Idaho Falls on October 22nd, the symptoms reached their most concerning levels. My baby was unable to lift his head and limbs, was extremely lethargic, unable to open his eyes, not crying, refusing to eat, and could not close his mouth. He was rushed to the Mountain View Hospital emergency room around 8 pm. When we entered the emergency room, we were immediately brought back for care by a large team of staff. My baby then had his temperature taken twice rectally, had blood drawn, and had a urine sample taken using a catheter. During all of this, my baby did not react at all. He was then admitted to Mountain View Hospital, where he stayed from October 22nd to 24th of 2025. During my baby’s stay, he was put on a feeding tube along with oxygen. My baby was also administered a glycerin suppository, which delayed the results for the Infant Botulism test. On the night of October 23rd, my baby’s staff realized that he was not processing formula, and the formula had to be removed via his feeding tube. On the 24th of October, the doctors were concerned as there was no improvement in my baby. The doctors proceeded to consult Intermountain Health Primary Children’s Hospital in Salt Lake City, Utah, where it was discussed that Infant Botulism was an extreme possibility for my baby. At that point, both hospitals agreed that it was in the best interest of my baby to have him medivac’d via plane to Intermountain Health Primary Children’s Hospital.

While being medivac’d to Intermountain Health Primary Children’s Hospital in Salt Lake City, Utah, my fiancé had to collect my dog from a boarding facility and “race” down to Salt Lake City with all our personal items to meet my baby and I at Intermountain Health Primary Children’s Hospital in Salt Lake City, Utah. My baby and I arrived at Intermountain Health Primary Children’s Hospital in Salt Lake City, Utah, and were immediately rushed to the Pediatric Intensive Care Unit (PICU). My baby was then attended to by four nurses, a neurologist, and additional staff. At this point, I was finally convinced to get rest at a hotel versus staying in the hospital room with my baby. This decision was extremely emotionally difficult as I felt like I was abandoning my baby. However, I knew that I needed proper rest to adequately care for my son.

My baby received BabyBIG on October 25th while still in the PICU. He received treatment even though, at the time, he was not diagnosed with Infant Botulism due to his symptoms being so concerning to hospital staff. The California CDC agreed to this treatment even without a positive test for Infant Botulism. My baby was then moved from the PICU to the long-term care unit on the 27th of October to monitor his care. Once moved to the long-term care unit, we contacted and were approved by the Ronald McDonald organization for long-term housing due to the cost

of staying in hotels for an extensive amount of time. During the entire time of our stay in Salt Lake City, we also had to pay for the boarding of our family dog.

Between October 27th and November 30th, I had multiple conversations with the Utah CDC, California CDC, and Washington State CDC, and insurance to explain the situation and to turn in the ByHeart formula for testing for Botulism. During a call with Washington State Insurance, I was pressured to ask the Intermountain Health Primary Children’s Hospital staff if my baby could be transferred to Tennessee or if my fiancé could fly to Tennessee to establish residency due to the enormous cost of care for my baby. My baby was released from Intermountain Health Primary Children’s Hospital in Salt Lake City on November 30th in the middle of a snowstorm.

During the long-term care for my baby, Halloween and Thanksgiving were missed with family due to our family not being able to afford travel expenses. My car’s registration also expired, causing frustration and fear while driving in Salt Lake City. This resulted in the title having to be sent overnight by mail to get a travel permit. While in Salt Lake City, my family had to receive my household goods from United Van Lines in Tennessee due to being in the process of moving.

My baby had to receive physical therapy to be able to return to bottle feeding. During this time and to this day, he has a weakness in his ability to lift and control his neck/head. My baby struggles to roll over from “tummy time” to back. My baby is not able to sit up on his own and is barely able to with assistance. Having Infant Botulism has delayed my baby’s developmental progress. My baby is unable to eat baby food because he is unable to support his head and upper body. My baby’s attitude/personality has changed significantly. My baby now becomes easily frustrated and enraged with the simple milestones that he should be hitting for his age.

This whole experience was an emotional rollercoaster due to it taking 17 months and fertility treatment to conceive. Some days, we were told that my baby could have died. Other days, we were waiting for him to get better. This has resulted in me becoming overprotective with my baby and not wanting to leave the house due to fear of my baby getting sick again. My baby is now only allowed to be held by close family members, and they are required to wash their hands before holding him. My baby, my fiancé, and I experience sleep issues due to remaining stress from this experience.

Baby 11: When my daughter was sick with botulism, I felt constant, overwhelming terror. In the 7 months between her illness and the recall, I blamed myself for what happened. Since hearing of the recall, I have been anxiously fighting for answers but feeling powerless. My daughter is 1 of the 51 infants impacted by this outbreak but she is not just a number. She is a sweet, playful, strong little person who survived a harrowing experience. 

Republished with permission from Bill Marler and Marler Clark. Copyright (c) Marler Clark LLP, PS. All rights reserved.

Source: https://www.marlerblog.com/case-news/let-the-botulism-babies-and-parents-speak-for-themselves/