Recalled Product Description

The recall affects Nara Organics Whole Milk Infant Formula sold nationwide through Target stores, Target.com and Nara.com between July 2025 and June 2026. Recalled products include:

• Nara Organics Whole Milk Infant Formula, powdered infant formula
• Products sold in retail stores and online through Target and Nara Organics
• All lot codes and all expiration dates

The Symptoms of Botulism

Infant botulism is a rare but serious illness that can occur when babies ingest Clostridium botulinum spores or toxins that attack the nervous system. Symptoms may include:

• Constipation
• Change in facial expression
• Ptosis
• Loss of head control
• Drooping eyelids
• Generalized weakness
• Difficulty swallowing, poor feeding
• In severe cases, respiratory failure 

Cook Children’s Expert Recommendation

Mary Suzanne Whitworth, M.D., medical director of Cook Children’s Infectious Diseases, previously advised parents to seek medical attention right away if an infant develops symptoms of botulism. Symptoms can take days or even weeks to appear after exposure. Families with concerns about recalled products or possible symptoms should contact their pediatrician for guidance and evaluation. If the infant is having trouble breathing or severe weakness, it’s best to call 911 immediately or proceed to the nearest emergency department.

The FDA recommends keeping any remaining formula away from children and other food products. Families who purchased the recalled formula may be eligible for a refund through Nara Organics or Target.

For more information about infant botulism and symptoms to watch for, read our previous coverage on infant botulism and formula safety.

Infant botulism is an illness caused by ingesting Clostridium botulinum spores or toxins that attack the nervous system.

Mary Suzanne Whitworth, M.D., medical director of Infectious Diseases at Cook Children’s, explains that infant formula has not been shown to cause infant botulism previously, noting this is the first time.

“Preliminary testing reveals the possible identification of Clostridium botulinum in one of the cans of formula, with confirmation still pending,” said Dr. Whitworth.

The CDPH Infant Botulism Treatment and Prevention Program (IBTPP) reported an increase in botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 15 cases included in this outbreak are reported to have consumed ByHeart brand powdered infant formula.

The FDA notified ByHeart on Nov. 7, and the company announced Tuesday, Nov. 11, a voluntary recall of all ByHeart Whole Nutrition Infant Formula and single-serve Anywhere Pack™ sticks.

Product Details for Voluntary Recall:

Can UPC: 85004496800

Anywhere Pack™ UPC: 85004496802

Product Image:

Photos courtesy of FDA

What Consumers Should Do:

Impacted consumers should immediately discontinue use and dispose of the product. 

Botulism is uncommon in dairy products or infant formula and is naturally occurring in environmental sources such as soil, select vegetables, and dust. The ByHeart brand of formula accounts for 1% of formula in the United States and the recall is not expected to result in a general formula shortage.

Officials in several states have collected leftover infant formula for testing. The testing is underway, and results are not yet available, but are expected in the coming weeks.  

What are the symptoms of botulism?

Symptoms of infant botulism can take as long as several weeks to develop following formula ingestion.

• Constipation
• Change in facial expression
• Ptosis
• Loss of head control
• Difficulty swallowing, poor feeding
• Generalized weakness
• In severe cases, respiratory failure

If your infant exhibits any symptoms or you are concerned they may have been exposed to the recalled formula, call your pediatrician.  If the child has difficulty breathing or severe weakness, they should call 911 or proceed to the nearest emergency department.

Finding infant formula on store shelves can still be tricky if you’re shopping for specialized types made for premature infants or babies with digestive complications.

Nutritional experts at Cook Children’s say some patient families are struggling even though formula availability generally has improved in recent months. The 2022 shortages have been blamed on a manufacturing recall and supply chain disruptions.

Brand options tend to be limited for preemies, who require formulas with higher calcium, phosphorous and protein for their bone and brain development. Likewise, infants who undergo surgery on their stomach or intestines might need certain easy-to-digest formulas.  

We spoke with three registered dietitians – from the Cook Children’s Neonatal Intensive Care Unit (NICU), the N.E.S.T. Clinic, and the Gastrointestinal Clinic – about tips and support for parents when the formula their baby takes is out of stock.

Their advice? Consider switching to another appropriate brand. Use the imported formulas that received approval from the U.S. Food and Drug Administration. Ask your pediatrician for samples. Don’t dilute formula or make your own version. And don’t give up.  

“I still see grocery stores with formula shelves that look about half empty or less,” said Hayley Spinks, a clinical dietitian in the NICU. “If you’re looking for a specific formula, it doesn’t really matter if the shortage is getting better overall. If you can’t find the formula that your baby needs, it’s really a big deal.”

One resource the dietitians share is a substitution list they created to help families know which brands fall in categories for particular needs. The substitutions list includes standard formulas, premature formulas, reduced lactose formulas and more. Go here to view the formula substitution chart.

The shortage continues to cause challenges and frustration, but dietitians are working to help parents find solutions. Here are their viewpoints.

In the NICU

Dietitians in the NICU monitor growth of the smallest babies, who sometimes need fortifiers added to their feeding regimen. When a preemie product runs out of stock, Spinks said, they turn to alternatives with the right nutritional components that the infant can tolerate. Signs of formula intolerance may include diarrhea, vomiting and belly bloating.

Before patients are discharged, Spinks and her colleague in the NICU like to ask the parents whether they’ve been able to find the formula they need. “Some moms are telling me that they’ve looked and they can’t find the formula that their baby is on,” she said. Others tell her they’ve enlisted relatives and friends to help search the stores.

Spinks makes a habit of checking the formula aisle when she’s shopping. She also belongs to formula finder groups on social media. “I’m always trying to keep my eye on the situation of what we can expect,” she said.

She encourages parents to have confidence in the safety of formulas that have been imported since May to relieve the shortage in the United States. But she cautioned that the measurements might differ (milliliters versus fluid ounces). Always follow the recipe on the can.

In the N.E.S.T. Clinic

The Cook Children's N.E.S.T. Developmental Follow-up Center (cookchildrens.org) provides support, interventions and care coordination for NICU babies as they transition home.

 “A majority of our patients require specialized formula either to meet their increased nutrient needs from prematurity or to improve their tolerance and absorption,” said registered dietitian Kayla Harrell.

Harrell said the shortage has forced some patients to change formula multiple times, incurring the risk of tummy distress, allergic reactions and other symptoms of intolerance. She has seen some improvement in availability. But parents tell her stories of driving up to two hours to track down formula or shipping it from out of state.    

For children with medically complex dietary situations, Harrell said, the formula hunt can be difficult and heartbreaking.

“You are not alone,” she said. “We are always here to help find the best solution for your precious child.”

In the GI Clinic

Gastrointestinal conditions can include bleeding, inflammatory bowel disease, chronic liver disease, swallowing dysfunction and nutrition absorption disorders. Some patients require formula fed through gastrostomy tubes called G-buttons.

Chelsea Barrow, a registered dietitian, said many children with GI problems have significant allergies, growth failure or reflux that causes them to rely on highly specialized formulas delivered from medical supply companies. Some of these formulas have gone in and out of stock, causing shipments to be delayed or partially fulfilled, Barrow said.

“Families are telling us they are driving around everywhere to find formulas,” she said. “They’re unable to find formula on the shelves or online. There’s limited access to grocery stores and pharmacies in their small rural towns. Families are asking if anyone has formula to spare or looking to social media for options.”

Barrow said it’s important to communicate with your health provider regarding brand substitutions. Not all formulas are interchangeable for individual patients, and mixing instructions can vary between brands. She urges patience as the dietitians navigate the inconsistent formula availability by adjusting orders, communicating with medical supply companies, fielding phone calls and continuing to see a full clinic load.

“There is indeed a light at the end of the tunnel with the return of many specialized formulas,” she said. “We are all working very hard and long hours to ensure families have something safe to feed their child.”

RELATED: Two Cook Children’s pediatricians shared their guidance on the infant formula shortage. Click here to watch videos in English and Spanish. 

August is National Breastfeeding Month.

And as much as I hate the word “journey,” allow me to tell you about my breastfeeding journey.

I figure there’s a lot of curiosity out there about a pediatrician’s breastfeeding experience. I mean I sit in my clinic rooms all day counseling about it, right? So surely it was an easy task for me? Surely I would sit in daily joyful motherhood bliss while my babe nursed happily with ease and comfort, right?

Heck. No.

In fact, I disliked a lot about breastfeeding. But I loved some of it, too.

(And guess what? GASP! This pediatrician used some formula, too! What? Did she say the F word?)

Before I gave birth to my first kid, I knew breastfeeding could be challenging for some moms. I didn’t worry or fret about it too much, though, because how hard could it be?

I mean, you just put the baby on the boob, right? I’m a pediatrician! I got this!

Ahahahahahahha.

My first kid refused to latch from day one. I worked with lactation consultants. I struggled with pain. I had his mouth anatomy evaluated (all was fine). I tried shields. I had supply issues. My kid screamed. Every. Nursing. Session. And I cried every nursing session. His reflux was constant and affected positioning, length of feeds, and general happiness.

My postpartum anxiety was vicious. And made everything probably 10 times worse than it already was.

So, I decided to pump. Exclusively.

And it was the hardest damned thing I’ve probably ever done.

It satiated my need for control in a situation where I felt I had no control. But it was hard. And mentally and physically exhausting.

I’d pump in my office many times a day, running late for patients and adding stress to an already stressful day. And while my also-pumping work partner would pull out 10 ounces at a time when she pumped during lunch with me, I’d get a measly 3 or 4.

And every day, I went into the bathroom and cried. What was wrong with me? Why was motherhood feeling so robotic and protocoled and cold? Why did I cry for 45 minutes if I spilled a bottle?

But I knew pumped milk was so beneficial to my baby. So I kept on going. For 6 months. Until my supply tanked because I couldn’t pump enough at work. So we used formula. And guess what? My baby survived. And I survived.

It took such a mental toll on me to not be able to breastfeed my child that when I was pregnant with my second, my husband and my mom both nervously asked me…”you have some cans of formula just in case…right?”

They asked me this out of the kindness of their hearts, and I responded with, “yep! In the closet!” because I too remembered the dark days. And I wanted the experience with my next baby to be different.

And it was different.

Guess who breastfed like a champ? My next kid.

And the breastfeeding experience was great. And flawless. And so easy. And tear-free.

I loved bonding with my child in this special way. I loved feeling like nutrition and protection were transferred to her from my body. I even loved the exhausting 3 am feeds.

So why tell you all this?

To let you know that every mother is different, just as every child is different.
To let you know you aren’t alone if you felt breastfeeding was a struggle you totally weren’t prepared for.
To let you know even the professionals are human, and struggle just as much as you do.
To let you know it is okay to both love and hate breastfeeding.
To let you know I (and any pediatrician) will never judge you for the choices you make in how you feed your child.

The recall in February from Abbott Nutrition has placed extra pressure on the supply chain and some stores are limiting the amount a customer can purchase.

Bianka Soria-Olmos, D.O., of Cook Children's Pediatrics Haslet and Alice Phillips, M.D., of Cook Children's Pediatrics Cityview answer top questions for parents and caregivers.

RELATED: Do's and Don'ts of the Formula Shortage (checkupnewsroom.com)

A recall in February from Abbott Nutrition has placed extra pressure on the supply chain and some stores are limiting the amount a customer can purchase.

Here are some tips from the AAP, the U.S. Food and Drug Administration and our doctors.

Never dilute with water

Never dilute breast milk or formula with water. The extra water causes the sodium level in their blood to drop. Low sodium will lead to brain swelling which can cause poor feeding, lethargy, seizure and eventually death.

Do switch to a store brand

For most babies, it's OK to switch to store brands unless your baby is on a specific extensively hydrolyzed or amino acid based formula such as Elecare (no store brand exists), the AAP says. If you're unsure, talk with your pediatrician. Store brand formulas are equally regulated by the FDA, which has requirements for nutrients in infant formulas.

Don't make your own

The AAP and the Food and Drug Administration strongly advise against homemade formula because of serious health and safety concerns. “Although recipes for homemade formulas circulating on the internet may seem healthy or less expensive, they are not safe and do not meet your baby's nutritional needs," the AAP said. "Infant deaths have been reported from use of some homemade formulas.”

The FDA said it has “recently received adverse event reports of hospitalized infants suffering from hypocalcemia (low calcium)” that had been fed homemade infant formula.

In February, batches of three infant powdered formula brands were recalled because of possible bacterial infections. So far, four instances of infant illness have been reported to the Food and Drug Administration.

Do use breast milk

Breast milk is an option. Consider reaching out to a breast milk bank for support.

Don't substitute with alternative milk products

Be careful to avoid milk alternatives, like almond milk, oat milk and other plant-based milks. They are not recommended for infants under a year of age.

Don't buy from third parties

Consumers should also avoid purchasing imported formula or formula that has been diverted from normal distribution channels and relabeled, as it has the potential to be counterfeit, the FDA says. 

For example, if an infant formula is past the "use by" date, a counterfeit label may bear a false "use by" date to obscure the fact that the product may no longer contain the amounts of nutrients listed on the label and may otherwise not be of acceptable quality, the FDA says.

Do check with your trusted medical provider

Pediatricians often have samples or can connect with a formula brand representative for supplies if needed. Check with your local WIC office. They may also be able to help.

I encourage breastfeeding when possible, but FED is BEST. If breastfeeding isn’t working out for mom or baby, we have plenty of other options with formulas. There are so many types of formulas that the process of choosing which one is right for your baby may seem overwhelming.

What’s the difference between organic formula and non-organic formula?

Be comforted by the fact that all infant formulas are regulated by the FDA which requires a standard of basic nutritional needs. Both organic and non-organic formulas support the healthy growth and development of infants. The difference is organic formulas must be manufactured from organic milk that is sourced from cows eating an organic feed and have no added hormones or antibiotics, no GMOs, no artificial or synthetic ingredients and ingredients are grown without pesticides. Be aware that some organic formula brands that are only sold online are manufactured in Europe and do not have U.S. FDA approval, including some popular goat milk formulas.

What is the benefit of eating organic food?

There are dozens of scientific papers published on potential benefits of eating organic. In one U.S. study, eating an organic diet compared to a conventional diet showed a decrease in pesticides found in children’s and adults’ urine output but more research is needed to determine the connection between that and positive health outcomes. In another recent study, researchers found higher rates of antibiotic resistant E. coli bacteria in non-organic chicken. And in India, researchers recently determined that soil with organic fertilizer contains more nutrients, more good strains of bacteria and significantly lower concentrations of toxic heavy metals.

Do organic formulas have extra ingredients that make them better?

Many organic formulas advertise added prebiotics, DHA, ARA, lutein, and a variety of other ingredients to make formula as close to breast milk as possible. However, many non-organic formulas have these same added ingredients. Always read the label and ask your pediatrician if you have any questions.

Is there anything in organic formulas that is bad for baby?

A few organic formulas contain sucrose, which can cause excess weight gain and dental cavities.

Who should choose organic formula over non-organic formula?

Choosing organic formula over non-organic formula is a personal choice—not a requirement. If your household is committed to eating organic foods, you have the option to purchase organic formula for your baby. How nice it would be if ALL our food could be organic or fresh from a local farmer’s market, but that’s not how our food supply chain operates. And it’s okay. If cost isn’t a factor, eating organic foods and feeding your baby organic formula would be a nice bonus, so go ahead and purchase it if you’d like. But don’t feel bad by choosing the non-organic and generic formulas, as they have plenty of good nutrition for your growing baby.

In the wake a baby is dead and her mom has been charged with her murder. In addition, the baby’s dad has been charged with aggravated battery and cruelty to a child for diluting their baby’s breast milk with water, then refusing to take the child for medical care.

By the time they did take her to the hospital, she was already dead.

Unfortunately, this is not uncommon. I remember a similar case from years ago in which a child’s family was desperate for money and thought they could use extra water to make their formula last longer. In a study from Clinical Pediatrics, up to 25 percent of families considered “food-insecure” admitted to using various methods to make their formula last longer.

The problem is that extra water is not safe for babies. It causes the sodium level in their blood to drop. Low sodium will lead to brain swelling which can cause poor feeding, lethargy, seizure and eventually death.

Giving free water to babies is not just an issue of formula stretching. Families commonly ask during the summer months if their babies need extra water due to the heat. The answer is NO!

Some reasons babies don’t need water:

• Breast milk and formula is mostly water (80-90 percent). Babies don’t get thirsty. Their diet is primarily liquid.
• Water does not have nutrition or electrolytes babies need. If a baby is going to be drinking something, why not make it be something that can help them grow?

Babies can safely start to drink some water after six months but they still don’t need a lot. They can get one to three ounces during their meals if parents want to introduce and practice with a sippy cup.

Most pediatricians recommend breastfeeding as the primary source of fluid intake for up to one year of age (even longer is fine).

For those who choose not to or could not breastfeed, I recommend an iron-fortified formula until one year.

After one year, a healthy, normal developing children should be transitioned to a well-balanced diet.

Cow’s milk can be used as an easy source of calories, protein and calcium but there’s nothing magical about it. If your child doesn’t like it, or you choose not to, just make sure that they are getting a nice rounded diet.

So, what about toddler formulas and toddler drinks?

The formula companies would like you to believe that they are an essential part of a toddler’s diet. They have added components to make them more attractive including probiotics and DHA. They make the cans look similar to your infant formula, to make it feel like the transition is expected and necessary.

But, I think you can and should skip them, unless instructed by or prescribed by your pediatrician. Here are 3 reasons why:

Many of them have ingredients that I wouldn’t recommend for toddlers anyway: corn syrup and other caloric sweeteners for example.

We really don’t know much about what giving DHA to a toddler adds to his or development or intelligence. If you are worried about it, add some fish to your toddler’s diet.

Most kids get plenty of calories and nutrients from other food sources. They don’t need the added calories and the extra nutrients are unnecessary except for the pickiest, most restrictive eaters.

So, what is toddler formula?

Mostly hype and marketing.

What should you do about it?

Unless instructed by your pediatrician, save your money for college…and I mean it.

Here’s the calculation:

Assuming three 8 ounces cups of toddler formula per day, you will need about 70 cans of toddler formula from 12 to 24 months. Each can costs about $20. That’s a total of $1400 during that year. If you invested that $1400 over the next 16 years (until they reach college age) and averaged 10 percent growth, you’d have about $6,500 by the time they reach college age.

Here are 4 reasons goat's milk is dangerous and could even be deadly:

1. It is usually not pasteurized which can lead to all kinds of bad infections (listeria most commonly).
2. It has more protein so baby's kidneys can't handle it well. This along with high sodium level can lead to strokes.
3. It doesn't have enough folate which can lead to anemia.
4. It doesn't have the same electrolytes which can lead to extra acids building up in the baby's body. This causes multiple downstream problems.

Breast is best. Modern formula is really, really good too.

Goat's milk is nothing to kid around with.

The numerous health benefits of breastfeeding cannot be denied. Some of them might be overstated at times but, all in all, I believe that breastfeeding is best.

I know there are times when, for whatever reason, moms cannot or choose not to breastfeed. Fortunately, we have come a long way from the old days of evaporated milk formulas of the 1920s to where formula feeding is a very reasonable alternative for those moms. I believe that families should be properly educated and supported in their feeding decision no matter what it is.

If you chose to formula feed or plan to, you can stop reading now. This is not one of those articles meant to shame someone for their choice. This post is a message in support of moms and families who choose to breastfeed and need a little help to determine if everything is going OK.

“Seven percent is average, over 10 percent I start to get worried.”

Most moms know (or read or were taught) that babies lose weight in their first few days of life. If not, that one week checkup is pretty emotional when they place their babies on the scale and the number is lower than their birth weight. Think about it, a 10-pound baby can drop to as low as 9 pounds and still be considered normal weight loss, but you would certainly worry from the time the baby was weighed until I came in the room to tell you everything is OK.

I have been quoting this 7 percent/10 percent mantra since I started practice. It’s partially wrong, at least for breast fed babies. Why? They can actually lose more and still be normal.

A study released in Pediatrics in December showed that breastfed babies could lose more than 10 percent and still be normal, especially babies born via caesarean section. The graphs enable a pediatrician to look at a baby’s weight loss day-by-day and determine if the weight loss is excessive. The bottoms of the weight loss peak occur on day six for both vaginal and c-section but the peaks occur at 11 percent and 12 percent respectively.

Why does this matter?

Any mom who has had trouble getting their baby to grow on breastmilk knows the pressure to start formula that can be applied by doctor, nurses or family members. While, I don’t believe that having mom give formula when appropriate ruins her chances of breastfeeding, I certainly don’t want to be pushing families to supplement when it isn’t necessary. Therefore, I plan to start implementing these guidelines into my practice so that I can best support breastfeeding moms in their effort to breastfeed.

If you are having a baby and are planning to breastfeed, it might be helpful for you to be aware of them as well.