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 November 21, 2025
Texas babies have been falling sick with infant botulism. As more suspected cases are confirmed, this number will likely increase.
What do these babies have in common?
They all consumed ByHeart formula. A whole nutrition formula that has recently tested positive for the harmful, toxin-producing bacteria – Clostridium botulinum.
While Texas babies have been the hardest hit in this outbreak, families across the country are frantic with hospitalized newborns.
Here’s what we know so far about the infant botulism outbreak so far!
As of November 20, 2025, at least six Texas babies have been linked to an ongoing infant botulism outbreak that has at least 31 total confirmed cases across 15 states. In addition to the ones in Texas, babies from Arizona, California, Idaho, Illinois, Kentucky, Maine, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, and Washington have fallen sick.
All 31 babies have been hospitalized. No deaths have been reported.
Illness onset dates back to August 9, 2025, with the most recent date of illness onset of November 13, 2025.
Specialized laboratory testing is required to confirm infant botulism in patient samples. These tests can take weeks to complete, so it is possible we will continue to see reports of more cases.
Complicating matters further, the recall was not successful. The U.S. Food and Drug Administration (FDA) has received reports of ByHeart Whole Nutrition infant formula remaining on store shelves, despite the recall announcement.
Texas parents should be extra vigilant when shopping for infant formula. Recall notices have been published, yet some retailers failed to remove the potentially contaminated product from store shelves.
According to the FDA, multiple Walmart, Target, and Kroger locations continued to sell ByHeart formula after the recall related to the infant botulism outbreak was announced. One or more Sprouts Organic Market, Safeway, Jewel-Osco, Shaw’s, and Star Market locations also failed to remove the product. Allowing this potentially tainted product to make it into the homes and bellies of innocent babies.
The initial recall for ByHeart Whole Nutrition infant formula only included select lots. However, as more babies fell sick and products began testing positive for the harmful bacteria, the recall was updated to include ALL ByHeart infant formula products.
This includes all formula can and single-serve “anywhere pack” sticks.
Overall, with six confirmed cases, Texas babies have been the hardest hit in this infant botulism outbreak. Arizona, California, and Oregon have three to four cases each. The remaining impacted states have one or two confirmed cases.
Picture from FDA
According to Galveston County Health District, at least one of those Texas babies with infant botulism is being treated in that local county.
“The Galveston County Health District (GCHD) is working closely with the Texas Department of State Health Services (DSHS), the Centers for Disease Control and Prevention (CDC), and U.S. Food and Drug Administration (FDA) regarding a confirmed case of infant botulism in Galveston County.”
According to the Health District News Release, on November 21, 2025, a four-month old is currently hospitalized at Texas Children’s Hospital and is on a ventilator and is currently being treated for infant botulism.
The infant is receiving BabyBIG (Botulism Immune Globulin Intravenous), the recommended treatment protocol for infant botulism.
Parents and caregivers of Texas babies who may have consumed ByHeart infant formula should take certain precautions.
First, discontinue use of recalled products. All ByHeart infant formula products have been recalled. Do not feed your infant formula from this brand.
Record the lot number and best by date. This information may be important for traceback investigation activities. Also, label any leftovers with “DO NOT USE” and store somewhere safely for at least 30 days.
After 30 days, if no symptoms develop, the package can be discarded.
Be sure to clean any bottles, surfaces, or feeding equipment that may have come into contact with ByHeart infant formula. Use hot soapy water or a dishwasher to clean all of these items.
Monitor infant for symptoms of infant botulism.
Infant botulism is an intestinal illness caused by ingesting Clostridium botulinum bacterial spores (or a related species).
These spores can temporarily colonize the infant’s large intestine and produce a type of neurotoxin called botulinum neurotoxin. This neurotoxin can have serious or even fatal consequences if not treated quickly.
It is rare for those over a year old to experience this type of illness because the natural bacteria in a health digestive tract prevent botulism-causing bacteria from lingering in the intestines. The undeveloped gut microbiome of those under one year is not strong enough to do this. Because the infection is different, symptoms often appear differently too.
For those over a year old, botulism is caused by consuming food already contaminated with the toxin. People get sick from consuming the toxin, not the bacteria.
For this reason, infant botulism often has a slow progression of symptoms. Whereas botulism in those over one year old is typically a faster onset.
Babies with infant botulism may experience any combination of symptoms associated with the illness. Severity may begin mild (almost unnoticeable) and worsen over time.
Some of the more common symptoms may include:
According to the U.S. Centers for Disease Control and Prevention (CDC) “symptoms of infant botulism, which is diagnosed clinically, can take as long as several weeks to develop following formula ingestion.”
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.
If your child has consumed ByHeart infant formula and has become sick, your may have a legal case. Medical bills, lost work, and other burdens associated with foodborne illness add up.
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)