ByHeart Infant Formula Recall: Your Questions, Answers & Next Steps

If your baby has been using ByHeart formula, you’ve likely seen the recall headlines. The company has voluntarily recalled all powdered formulas after several infants developed infant botulism, a rare but serious illness.

For now, families are being advised to stop using ByHeart formula out of caution. (NOTE: Do not throw the cans away, but put them away in a secure, temperature-stable area. This may be helpful if more information is needed during the recall). 

For many families, this recall feels unsettling. It’s important to understand what’s happening, what signs to watch for, and how to safely move forward. I also want to ease the emotional weight many parents are feeling, because feeding your baby with love and intention is never something to feel guilty about.

What happened and why it matters

In early November, the FDA and CDC began investigating a multistate outbreak of infant botulism. As part of that investigation, epidemiologic and lab data pointed to ByHeart Whole Nutrition powdered infant formula as a possible source.

Since then, federal and state health officials, including the California Department of Public Health, have been working together to trace the source. The CDPH reported Clostridium botulinum bacteria in an open can of ByHeart formula fed to an affected infant. This finding, along with additional confirmed cases, led to a voluntary recall of all ByHeart formula products nationwide, including cans and single-serve “anywhere” sticks.

As of now, 84 infants nationwide have been treated for infant botulism. Among infants who were exposed to powdered formula, more than 40% had consumed ByHeart (15 cases), an unusually high number given that the brand makes up only about 1% of U.S. formula sales. Meaning the brand is disproportionately represented among the recent cases. Investigators haven’t found links to any other formula brands.  Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. No similar links have been found with other brands, but investigators continue to test samples and monitor all formula manufacturers closely as part of the ongoing investigation.

At this stage, the investigation is ongoing. Additional testing is underway at ByHeart’s facilities to determine exactly where and how contamination may have occurred.

What is Infant Botulism?

Hearing the word botulism can instantly spark fear. It’s a serious illness, but it’s also extremely rare. Understanding what it actually is (and how rare it remains) can help ease that anxiety and keep your focus on what matters: recognizing symptoms early and knowing when to reach out to your child’s doctor.

Infant botulism is caused by Clostridium botulinum, a bacteria that produces a toxin affecting the nervous system. It’s extremely uncommon, but when it happens, it can make babies very weak and affect their ability to feed or move normally.

Younger babies, especially newborns and infants under six months, are most at risk. Their immature gut and immune system make it easier for spores to grow and release toxin. As babies get older, their intestines mature and the risk drops significantly, especially after solids are introduced and by the time they’re past one year old.

Here are the most common questions parents ask about botulism:

Symptoms can develop gradually, often over several days. Early signs can look like things you might notice with other illnesses, which is why context (like recent ByHeart formula use) matters.

Here’s what to watch for:

• Constipation (often the first sign)

• Weak sucking or poor feeding

• Drooling more than usual

• Floppiness or loss of head control

• Weak cry or less movement

• Trouble swallowing

• Breathing difficulties in more severe cases

If your baby has recently consumed ByHeart formula and shows any of these symptoms, it’s a medical emergency, so seek immediate medical attention.

Symptoms don’t show up right away. Based on what’s known about infant botulism, illness can develop anywhere from a few days to several weeks after exposure. That’s why experts recommend keeping your baby’s formula containers and monitoring for symptoms for about 30 days after their last use of ByHeart formula.

No. Botulism isn’t something that spreads from person to person. A baby can only get sick if they ingest spores of Clostridium botulinum (for example, from contaminated food, soil, dust, or, very rarely, formula).

Yes. Most infant botulism cases happen when babies ingest spores naturally found in soil or dust. A small number of cases have been linked to foods like honey, which is why honey isn’t recommended before age one. This outbreak is unusual because the bacteria were found in a commercial infant formula, which is extremely rare. That is why investigations are ongoing and formula testing is vital to confirm if the source is the formula or other entities. 

Treatment involves an antitoxin called BabyBIG (Botulism Immune Globulin Intravenous (Human) (BIG-IV)), which helps stop the toxin from causing further nerve damage. Most babies who receive timely treatment recover fully, though it can take weeks or months for strength and feeding to return to normal. Early recognition and treatment are key to recovery.

If your baby is feeding well, alert, and moving normally, that’s reassuring. Continue to monitor for any of the symptoms above for about 30 days after their last exposure. Keep the formula container if you still have it, as health officials may request it for testing if any symptoms appear. Store it safely away and label: DO NOT USE.

Even if spores were present in a product, that doesn’t mean every baby who consumed it would become ill. Infant botulism is very rare, and most exposed infants never develop symptoms. The illness only occurs if the spores multiply and release toxin inside the baby’s intestines, something that rarely happens. Not all babies exposed will have this occur. 

The risk is higher with exposure, but it’s not 100%. And importantly, almost all babies who do get sick recover fully with prompt treatment.

So, if your baby seems fine, keep watching them, but try not to panic or think the worst. Staying observant and informed is the safest and most helpful approach.

No. The concern is with the formula powder itself, not your bottles. Just wash all parts in hot, soapy water (or run them through the dishwasher) and let them air-dry. A one-time sterilization is optional, but not required. If throwing the bottles away makes you feel better, you can do what feels best for you. 

How does this happen?

With everything going on, it’s understandable that formula prep might feel even more stressful than usual. Between switching brands and double-checking safety, you may find yourself second-guessing every scoop.

Here’s what’s helpful to know, and why staying aware, not anxious, is what truly protects your baby.

Formula Isn’t Sterile

Powdered infant formula is made by spray-drying milk and nutrients into powder. During that process, bacteria from the environment can land in the powder before it’s sealed. This is true for every powdered formula, no matter the brand or cost.

That doesn’t mean it’s unsafe. The body handles small exposures easily, and strict manufacturing rules make serious contamination extremely rare.

How Contamination Can Happen

Certain bacteria, like Clostridium botulinum (which can cause botulism) or Cronobacter sakazakii (linked to a few newborn infections), can survive in dry environments.

If introduced at any point during production, from raw materials to equipment or packaging, they can persist in trace amounts.

That’s why recalls happen quickly and out of an abundance of caution, even if only a few cans or batches are affected. These recalls are signs that oversight systems are working, albeit this is extremely stressful.

By Heart claims no unopened cans tested positive for Clostridium. What does that mean?

When officials say no unopened cans tested positive for Clostridium botulinum, they mean that factory-sealed cans pulled for testing didn’t show contamination once opened and tested in a lab.

Those cans were sealed before testing, but opened under sterile conditions to check for bacteria. Only one opened can from an affected household tested positive, which means investigators can’t yet say whether the contamination happened before or after the can was opened.

This is why the recall remains precautionary until testing is complete, but pulling all batches is the safest step for families.

Regulation, Oversight, and Testing

Infant formula is one of the most closely regulated food products in the U.S. The FDA sets strict rules for nutritional composition, cleanliness, and quality control.

Many companies also use third-party testing to confirm safety, looking for contaminants, heavy metals, and microbes throughout production.

ByHeart, for example, has stated that their formula undergoes more than 1,000 tests, including third-party lab checks. However, as of now, no U.S. or global formula manufacturer is required to test for Clostridium botulinum spores. The current investigation is meant to better understand whether this should change moving forward.

The recent ByHeart recall was initiated voluntarily and out of precaution. While no direct link has been proven, the recall shows the system is doing what it’s designed to do: pause, test, and protect.

Why It’s Still So Rare

Infant botulism remains extremely uncommon. Most cases happen when babies ingest spores from soil, dust, or honey, not from formula.

Manufacturing oversight, safety audits, and rapid recalls are why serious outbreaks are rare and contained quickly.

Preparing and storing formula safely

This is also why safe preparation at home matters. Bacteria don’t multiply in dry powder, but they can multiply fast once the formula is mixed with water and left at room temperature.

If you want a refresher on how to safely prepare, store, and serve both powdered and ready-to-feed formula, I walk you through it step by step in this video:

🎥 How Do I Make and Store Baby Formula?

It covers what really matters for your baby’s safety, like preparing, correct storage, and traveling with formula, so formula feeding feels simple and stress-free again.

Next steps for families using ByHeart

If your baby has been using ByHeart formula, you’ll need to switch to a different brand right away. The good news is that there are safe, nutritionally equivalent alternatives available, and most babies adjust without major issues.

Here’s what to do next:

1. Stop using any ByHeart formula. All ByHeart powdered formulas are included in the recall. Store any open or unopened cans in a safe place and label them “Do Not Use.” Keep them for at least 30 days in case your local health department requests them for testing.

2. Reach out to your pediatrician. Especially if your baby has medical needs, was born preterm, or uses a specialty formula. Your pediatrician can help choose the best replacement and guide you through a safe transition.

3. Choose a replacement formula. For healthy, full-term infants, most standard cow’s milk–based formulas are nutritionally similar. Common options include:

• Bobbie Organic Whole Milk Infant Formula

• Kendamil Organic Infant Formula

• Similac 360 Total Care Infant Formula

• Gerber Good Start GentlePro Infant Formula

• HappyBaby A2 Organic Infant Formula

Depending on why you were using ByHeart (based on ingredients), you can find comparable options based on desired composition. 

These all provide complete nutrition for infants and are widely available. For more help choosing a formula, check out this PedsDocTalk YouTube video: What Baby Formula Should My Baby Use?. And watch this one on reading formula labels to find a comparable option for you. 

4. Avoid homemade or substitute options. It’s not safe to use cow’s milk, goat’s milk, or plant-based milks (like almond, oat, or soy beverages) before age one unless your pediatrician gives specific guidance. These don’t meet an infant’s nutritional needs and can cause serious health problems.

The emotional side of this recall

Beyond the headlines and health updates, there’s the part that doesn’t get enough attention: the emotional toll this takes on parents.

If you’re feeling anxious, frustrated, or even guilty, you’re not alone. For many families, ByHeart wasn’t just a formula… it was a decision made with care. It represented trust in a brand that aligned with your values: clean ingredients, science-backed safety, something you felt good giving your baby. Having that trust shaken overnight can bring a wave of emotions: fear for your child’s safety, anger at the system, or guilt for using formula at all.

And underneath all of that is something deeper: a loss of trust. We’re told to do our research, choose carefully, and follow the rules. But moments like this remind us that even with all the research and intention, we can’t control everything. That’s unsettling for any parent, especially when it involves something as intimate as feeding.

You might also be thinking, “How can I be sure this won’t happen with other brands?”

That fear makes sense, but it’s important to know that this recall doesn’t mean formula as a whole is unsafe. Every formula manufacturer in the U.S. operates under strict FDA regulations, with ongoing inspections and required safety testing at every stage of production.

The truth is that no formula is 100% risk-free. Bacteria exist in our environment, and even with the most rigorous systems, the chance of contamination can never be brought to zero. That’s why regulation, testing, and proper preparation at home are all so important; together, they keep that risk extremely low.

I can’t speak to ByHeart’s internal processes or decisions, but no formula company ever wants to face something like this. My hope is that they continue to work transparently with federal and state officials and with families  to provide clear communication, support, and next steps as the investigation continues. 

No other brands have been linked to these cases, and all formula companies are now under even closer monitoring as part of this ongoing investigation. Formula-fed babies in the U.S. remain overwhelmingly safe, thanks to those safeguards and to parents like you who stay aware and attentive.

It’s natural to feel scared about illness, even when the actual risk is low. Fear is a reflection of how deeply you care. But staying grounded in the facts can help calm the noise: infant botulism remains extremely rare, and the oversight we’re seeing now, recalls, testing, investigations, exists to keep babies safe.

So instead of spiraling about what might happen, focus on what you can do right now: stay alert, know the early signs to watch for, reach out for care if something doesn’t feel right, and remind yourself that vigilance is not the same as fear.

Maybe you tried to breastfeed and it didn’t work out as you’d hoped. Maybe formula feeding was always your plan. Either way, this situation is not your fault. You’re responding to information that’s out of your control and making the best decisions you can with what you know now. Feeding your baby, whether breast or formula, is an act of care. Switching formulas right now isn’t a setback or failure, it’s a responsible, protective step. I formula-fed Ryaan, and I know how much time, thought, and emotion go into feeding decisions. That love and effort still stand, no matter what’s happening in the news.

It’s also okay if your feelings don’t match your logic. You can know, intellectually, that formula feeding is safe and loving, and still feel shaken. You can trust your pediatrician and a new company or formula and still feel skeptical of the system. Those emotions can coexist.

If you’re finding yourself spiraling in worry or guilt, take a breath and come back to what’s true: you are feeding your baby safely, with love and awareness, and that’s what matters.

For more on the guilt that can come with formula feeding, separate from any recall, listen to the PedsDocTalk Podcast episode “How Formula-Shaming Has Led to Overwhelming Guilt for New Moms.” It unpacks where this guilt comes from, how cultural messages feed it, and practical ways to move toward confidence and peace in your feeding journey.

Closing thoughts

This recall has understandably left many parents feeling uneasy and uncertain about what comes next. You’ve had to make quick decisions and process a lot of information, all while caring for your baby.

Here’s a quick recap of what matters most:

• Stop using ByHeart formula: all powdered products are included in the recall.

• Store cans safely and label them “Do Not Use” in case health officials request testing.

• Switch to a safe alternative: most standard cow’s milk–based formulas provide complete nutrition.

• Monitor your baby for changes in feeding, alertness, or movement over the next month.

• Reach out to your pediatrician with any concerns or questions.

You’re not alone in this. It’s okay to feel anxious, frustrated, or even angry. Those feelings come from wanting to protect your baby. What matters most is that you’re paying attention, staying informed, and taking steps rooted in care and caution.

We’ll keep sharing updates as more information comes out. In the meantime, focus on what you can control, including your awareness, your baby’s safety, and your peace of mind. You’re doing the right thing.

On The Podcast

More and more women are getting diagnosed with ADHD later in life, often after becoming parents, and it’s not because ADHD is “trending.” It’s because we’ve missed it for decades.

In this conversation, I talk with psychiatrist and author Dr. Sasha Hamdani about why ADHD in girls and women often goes unnoticed, how hormones and motherhood reveal hidden symptoms, and why self-understanding can be so freeing. We discuss stigma, emotional regulation, anxiety, and how parenting can bring clarity to our own neurodiversity.

If you’ve ever wondered why things got harder after kids, or why your child’s diagnosis suddenly made your own life make more sense, this episode will feel like a deep exhale.

Sleep training might be one of the most debated topics in parenting but it doesn’t have to be so polarizing. In this Follow-Up episode, I revisit my most downloaded episode, “We’re Losing Sleep Over Our Kids’ Sleep,” to talk honestly about what sleep training really means, the methods that exist, and how to decide what’s right for your family.

On YouTube

I see so many parents get caught up in trendy parenting labels like gentle, tiger, attachment, or free-range, but the truth is that most of these overlap with one research-backed approach called authoritative parenting. In this video, I explain what that actually looks like in real life by balancing warmth with boundaries, connection with consistency, and why decades of science point to it as the most effective style for raising confident and emotionally healthy kids. You’ll see real-world examples, simple explanations of the research, and practical ways to find your own version of calm and structured parenting without the guilt.

If You Missed it…

Ask Dr. Mona

An opportunity for YOU to ask Dr. Mona your parenting questions!

Dr. Mona will answer these questions in a future Sunday Morning Q&A email. Chances are if you have a parenting concern or question, another parent can relate. So let's figure this out together!