Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Botulism,Our Blog,Outbreaks & Recalls on December 28, 2025
Infant botulism is a rare but serious illness caused by ingesting a harmful, toxin-producing germ called Clostridium botulinum. A recent outbreak linked to ByHeart Whole Nutrition infant formula has hit headlines and the hearts of caregivers across the country as over 50 babies have been hospitalized and numerous impacted by this serious condition.
There is a lot to know about this scary condition. Join me as I answer some of the most pressing questions people have asked about infant botulism, information on the current outbreak linked to infant formula, and resources to turn to if your child has been impacted by this infection.
Infant botulism is caused by a bacterium called Clostridium botulinum. A germ associated with contaminated food and dust particles. It produces a toxin that can cause serious digestive upset in young children and adults. However, it impacts the underdeveloped digestive system of infants quite differently.
Botulism is often associated with improperly sterilized or inadequately processed or refrigerated home-canned and preserved food. Though honey exposure accounts for around 20% of cases. For this reason, some populations present a higher incidence of botulism due to the increased use of herbal medications and raw honey. Another source, as recent events have demonstrated, is infant formula. Clostridium botulinum spores are also found in the soil and dust. Exposure to these environmental components can lead to infant botulism in rare cases.
Certain commercially manufactured products, like cereal, granola, oats, or bread, contain honey. It is not recommended to feed honey or honey-containing products to children under one year of age due to increased risk of infant botulism. Parents and caregivers are advised to refer to the American Academy of Pediatrics best practice guidelines when feeding solids to infants. As manufacturing processes vary from product to product, there is a possibility that viable Clostridium botulinum spores may be present in those foods.
If your child has consumed a commercially manufactured product containing honey, monitor for symptoms of infant botulism. If you suspect your child has been infected, seek medical attention right away and notify your health care provider of the exposure.
While honey is not safe for babies under one year of age, a breastfeeding mother can safely consume to the product. Fortunately, botulism is not transmitted by breast milk. The spores are far too large to transfer from the mother’s body into her breast milk.
However, thorough hand washing practices should be observed, especially in households that consume honey. Care should also be taken to prevent the spread of honey to surfaces that may come into contact with the infant’s mouth.
Infant botulism is not very common. In the United States, it accounts for around 1.9 cases per 100,000 live births. Somewhere around 77 new cases across the country each year.
However, Infant botulism is the most common form of botulism. In fact, 70% of all new cases of botulism involve infants!
Infant botulism is different, in that the bacteria actually colonize and replicate in the large intestine. In older children and adults, this does not happen. Cases of botulism in adults and older children involve a reaction to consuming the toxin produced by these bacteria. Not the actual bacteria.
When an infant consumes something contaminated with Clostridium botulinum the bacteria colonize the large intestine. There they replicate and produce botulinum toxin. Within the body.
Medical science still has not understand all of the factors that make an infant susceptible to botulism spore germination, but an undeveloped microbiome is likely a strong contributing factor.
Botulinum toxins are very potent. More toxic than mustard gas! Even a dose as low as 1 mcg/kg can be lethal.
It enters the system and binds at the neuromuscular junction at presynaptic nerve terminals and inhibits acetylcholine release This is because the toxin blocks calcium channels in the body that keep this necessary balance.
When this happens toxin, producing what is called “flaccid motor paralysis.” It leads to generalized weakness, reduced muscle tone, and respiratory problems.
Unfortunately, initial infant botulism symptoms are often dismissed. Infants do not have the verbal ability to express what they are feeling or what is going on in their small bodies. These infant botulism symptoms are also similar to other common baby issues.
For example, the first indication of infant symptoms is diarrhea and vomiting followed by constipation. This is often missed entirely. Constipation is a common occurrence in newborns and infants.
What parents often notice first is when the baby feeds poorly. A breastfeed mother may notice that she remains engorged after feeding cycles. Babies may not finish the same amount of formula in their bottles as they have previously consumed. This may not be obvious, however. Because the amount of formula an infant consumes can oscillate up and down at different growth cycles.
Babies may also drool more. Teething, a natural developmental process, also elicits drooling in infants.
What usually gives parents and caregivers growing concern is when the infant becomes lethargic or listless. Sometimes described as “floppy.” Their cry may change to something smaller or weaker. Their breathing may become shallow and rapid. This is often what drives parents to seek medical attention and emergency care.
Even once addressed, the condition may still be overlooked. Doctors often attribute infant botulism symptoms to other conditions. Sepsis, Leigh disease, Guillain-Barre syndrome, dehydration, metabolic disorders, or other conditions with overlapping symptoms.
Further complicating matters, it can take quite a while for symptoms to ramp up. Incubation period can range anywhere from 10 to 30 before symptoms begin, with peak symptoms occurring in three to four months.
Presumptive diagnosis is performed based on infant botulism symptoms. However, both a stool culture and direct toxin assay are required to confirm infant botulism.
Toxin assays results returned fairly quickly. Often the morning after the specimen is received by the laboratory. Stool cultures, on the other hand, can take anywhere from a week to a month before they are available. For this reason, clinical observations from a physical exam are used to presumptively diagnose patients and treatment is administered long before the results are available.
Healthcare providers can diagnose presumptive infant botulism by performing three different tests in a physical exam.
One test involves taking the patient to a dark room, shining a bright light into their eye, and noting how quickly the pupil constricts. The light is removed when the pupil is fully constricted. The doctor will repeat this cycle every two to three minutes.
One of the infant botulism symptoms can be measured whether it takes longer or the eye is unable to fully constrict. This is a sign of constrictor “muscle fatigability.”
Another test also involves the eyes. The doctor will shine a bright light into the baby’s eyes and watch for purposeful efforts to avoid the light. They will observe whether or not the initial squirming and attempts to move away from the light occur and if they reduce. Reduced reactions over the course of one to three minutes are a sign of “fatigability.”
The third test is an indicator of reflex sucking. During this test, a clean fifth finger is placed in the infant’s mouth. The strength and duration of the reflex sucking is observed. If it is weak or poorly sustained, this is also a sign of “fatigability.”
Antibiotic therapy is typically not administered in infant botulism. Instead, an anti-toxin called BIG-IV is administered. BabyBIG® is the human-derived botulism antitoxin approved by the U.S. Food and Drug Administration (FDA) for treating infant botulism in October 2003. This medication significantly reduces the length of hospital stay and costs associated with infant botulism.
The single-dose treatment is administered intravenously over 30 minutes. BabyBIG® can rapidly improve symptoms. Particularly if administered within 24 hours of infant botulism symptoms onset. However, it is quite expensive. A dose of BIG-IV is upwards of $50,000. In California, this “per patient fee” is $69,300!
Additionally, around half of infant botulism cases require intubation and an advanced airway. Without this anti-toxin treatment, infected infants often require mechanical ventilation for longer periods.
Vaccination schedules are important to maintain. However, antitoxin treatment and the illness itself may interfere with vaccination effectiveness. The infant should recover muscle strength and tone prior to resuming immunizations. For live virus vaccines like measles, mumps, rubella, and varicella, vaccines should be held for six months after BabyBIG® treatment. Certain antibodies in this antitoxin treatment may interfere with the effectiveness of the vaccine. RotaTeq® and Rotatrix® should be delaved until normal bowel function has returned.
Fortunately, BabyBIG® treatment offers a protective level of toxin-neutralizing antibodies for at least six months. This enables Clostridium botulinum bacteria elimination and enough time for the baby’s microbiome to develop. Reports indicate that there has never been a recorded case where an infant acquired the disease more than once.
There have been reports of relapses though. Those cases often involved premature discharge where the infant had not fully recovered strength necessary to sustain feeding and breathing.
An infant can spread the illness by excreting both the toxin and the organism in their feces for weeks or even months after their own symptoms begin. Caregivers should take extra precautions when changing diapers.
Careful and thorough hand washing should be practiced after each diaper change. Soiled diapers should be discarded in an area where no people or animals can come into contact with them. Those with open cuts or wounds on their hands should wear gloves while changing diapers to prevent contact. Clostridium botulinum bacteria can enter the bloodstream through cuts and scratches, where it can cause serious, life-threatening illness.
A leaky diaper can also spread illness. It is a good idea to limit close contact with other small children during the months after illness.
Unless infant botulism leads to serious hospital-acquired complications, there are often no long-term consequences of infant botulism. Most infant botulism patients make a full and complete recovery. Fortunately, botulinum toxin does not penetrate into the brain, allowing patients to retain all of their intelligence, athletic ability, and otherwise develop normally.
The most recent infant botulism outbreak was linked to ByHeart Whole Nutrition infant formula. As of December 17, 2025 there were a total of 51 suspected or confirmed illnesses associated with the product. The last date for illness onset was December 1, 2025. All 51 babies required hospitalization. No deaths have been reported in connection to this outbreak.
Sick babies were traced back to Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.
There have been no recorded infant botulism outbreaks prior to the outbreak associated with ByHeart Whole Nutrition infant formula. Cases of infant botulism are generally sporadic and unconnected.
Infant botulism should be taken very seriously. If you suspect your baby has infant botulism, there are a few things you can do to help.
First, get medical help right away. Infant botulism can be fatal if not treated quickly. If your child has consumed ByHeart infant formula (or other infant formula) and is experiencing infant botulism symptoms, do not hesitate. Get medical help right away!
If possible, retain a portion of the product by carefully bagging it up and clearly labeling so that it is no longer consumed. This product could be useful for traceback investigation purposes. Otherwise, document the lot information for the product that was consumed. This information is also helpful.
You should also get advice from an infant botulism lawyer. An infant botulism lawyer understands product contamination and product liability cases and can help you through this difficult process.
The experienced infant botulism lawyers at The Lange Law Firm, PLLC are dedicated to holding food companies accountable for lapses in food safety that result in illness or injury.
An infant botulism lawyer can:
The Lange Law Firm, PLLC has recovered millions of dollars in product liability and food poisoning cases. They can help you too!
Call (833) 330-3663 for a free, no obligation consultation. Or fill out the online submission form, and someone will get back with you right away.
By Heather Van Tassell (contributing writer, non-lawyer)