Picture from U.S. Food and Drug Administration
ByHeart infant formula is a common food consumed by 13 babies recently diagnosed with deadly infant botulism. Several Federal agencies as well as state and local partners are investigating this outbreak. Unfortunately, this tragic number could rise as more information becomes available.
Where have these illnesses taken place? What products are being recalled? What are the symptoms of infant botulism?
Here’s what we know about the ByHeart infant formula botulism outbreak so far.
The California Department of Public Health (CDPH) Infant Botulism Treatment and Prevention Program (IBTPP) has received an increased number of reported cases of botulism type A infections between August 2025 and November 2025. At least 13 of these cases reported consuming ByHeart-brand powdered infant formula.
All 13 babies have been hospitalized for their illness.
So far, cases span 10 states. Including Arizona (1 case), California (2 cases), Illinois (2 cases), Minnesota (1 case), New Jersey (1 case), Oregon (1 case), Pennsylvania (1 case), Rhode Island (1 case), Texas (2 cases), and Washington (1 case).
Additional cases have pending laboratory confirmation.
No deaths have been reported at this time.
Several state health departments have collected samples from leftover containers of ByHeart infant formula.
This testing is in progress. Unfortunately, the results are not yet available. They are, however, “expected in the coming weeks.”
The U.S. Food and Drug Administration (FDA) say they have been in contact with ByHeart, Inc., the supplier of the common ByHeart infant formula. The firm has been advised to conduct a voluntary recall “due to the number of cases, severity of illness, and the strong epidemiological signal.”
In response to these findings, ByHeart, Inc agreed to initiate a recall for two lots of their ByHeart Whole Nutrition Infant Formula.
Infant Formula Recall
ByHeart Whole Nutrition Infant Formula
Lot: 206VABP/251261P2
Lot: 206VABP/251131P2
The two lots that sick infants have been reported to consume include Lot: 206VABP/251261P2 and Lot: 206VABP/251131P2. Affected products were sold online and distributed nationwide to major retailers.
The FDA’s ongoing investigation is working to determine where the contamination took place and if additional product may have been impacted.
According to the FDA, ByHeart Whole Nutrition Infant Formula only makes up an estimated less than 1% of all infant formula sold in the United States. There are no expected shortage concerns of infant formula for parents and caregivers at this time.
Infant botulism is an intestinal illness. This disease develops when spores of the bacterium Clostridium botulinum, or a related species, have been swallowed.
The spores can temporarily colonize the infant’s large intestine. These types of bacteria produce a type of neurotoxin called botulinum neurotoxin. This neurotoxin can have serious or even fatal consequences if not treated quickly.
In people over a year, botulism is caused by consuming food already contaminated with the toxin. People get sick from consuming the toxin, not the bacteria. When infection happens in those under one year old, the bacteria can actually make the toxin while still inside the body. Leading to slow onset, as opposed to rapid symptoms observed in older children and adults.
This is 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.
In fact, for those under one year old, the body is affected in different ways.
It is a “slow form of paralysis in infants,” says The Cleveland Clinic. It comes one very slowly. Gradually becoming worse over time. This makes it difficult to notice early. However, early medical care can make a huge difference in the outcome.
For a person who does not yet have the ability to tell you what’s going on or answer questions, this complicates things. Adding to that, babies with infant botulism are also alert, have no fever, and appear otherwise healthy.
Babies with infant botulism may experience any combination of symptoms associated with the illness.
Some of the 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.”
Stool or enema specimens are collected to diagnose infant botulism. This testing is usually performed by the state public health laboratory or the Centers for Disease Control and Prevention if the state laboratory does not have testing capabilities.
These specialized laboratory tests often take days to complete. However, clinical symptoms are sufficient to begin treatment.
Infant botulism is treated by BabyBIG®, a human antitoxin. According to policy, the state health department should be notified when BabyBIG infusion is complete. This is also a reportable illness to the CDC. So this organization must also be notified via the National Notifiable Diseases Surveillance System.
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 your situation, and theirs.
Botulism can be fatal if not treated right away. If your child has consumed ByHeart infant formula, or some other infant formula, and is experiencing symptoms of infant botulism, get medical help right away!
Your physician should notify the Infant botulism treatment and Prevention Program hotline at 510-231-7600 for a case consultation. The line is available 24/7.
If possible, retain a portion of the product (carefully bagged up and labeled so it is no longer consumed). This could be useful if investigators wish to test a sample from your opened container.
Otherwise, document lot information for the product that was consumed to be used in the traceback investigation process.
If you child has been impacted by infant botulism after consuming ByHeart infant formula, or some other brand of infant formula, it is a good idea to get legal advice. 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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