Image by Gregor Ritter from Pixabay
Initial infant botulism symptoms are often overlooked and attributed to normal baby behaviors. With an ongoing infant botulism outbreak linked to baby formula, it is important for parents to understand the early signs and know what to do if their child becomes sick.
Early treatment is associated with faster recovery and potentially fewer complications.
What causes infant botulism? What are the early symptoms? How is it treated? How is it diagnosed and treated?
Follow along for the answers to these questions, and more! But first, let’s talk about the current infant botulism outbreak.
The number of reported infant botulism cases is well over one hundred. However, as of November 19, 2025 only 31 cases have been confirmed in the infant botulism outbreak linked to ByHeart infant formula.
All 31 babies were hospitalized.
We expect more of these suspected cases to be added to the outbreak total as more information becomes available.
Texas has been the hardest hit in this outbreak, with at least six cases reported so far. Followed by Arizona, California, and Oregon. Other states with infant botulism cases include Idaho, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Pennsylvania, Rhode Island, and Washington.
The Make Food Safe Blog is monitoring the situation.
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.
Infant botulism is the most common form of botulism. In fact, 70% of all new cases of botulism involve infants! In the United States, this comes to around 1.9 per 100,000 live births and around 77 new cases each year.
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. Those cases primarily involve reaction to consuming the toxin produced by these bacteria. As opposed to the bacteria itself.
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. Though the amount of formula an infant consumes can oscillate up and down at different growth cycles.
Babies may also drool more. However, parents and caregivers often chalk this up to teething.
What usually gives parents 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.
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.
When an infant consumes something contaminated with Clostridium botulinum the bacteria colonize the large intestine. There they replicate and produce botulinum toxin.
Botulinum toxin is 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.
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.”
A 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.
This single-dose treatment is administered intravenously over 30 minutes. This treatment 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.
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 a food poisoning lawyer. A food poisoning lawyer understands product contamination and product liability cases and can help you through this difficult process.
The experienced Food Poisoning 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. They have 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)
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