Federal health officials announced a nationwide recall of all ByHeart Whole Nutrition Infant Formula in November 2025 following an outbreak of infant botulism that caused illness in dozens of babies across the United States.
The investigation remains ongoing, and parents who used the recalled formula are urged to stay alert for symptoms and seek medical care if concerns arise. Details continue to emerge over the ByHeart infant formula recall.
If your child shows symptoms of botulism or has a medical case after ingesting ByHeart Whole Nutrition Infant Formula, The Carlson Law Firm is prepared to help.
What Is Infant Botulism?
According to the World Health Organization, the majority of infant botulism cases occur in infants under 6 months of age when a baby swallows Clostridium botulinum spores. These spores grow in an infant’s digestive system and produce a toxin that interferes with nerve function.
Natural defenses in intestines prevent these spores from growing in most older children and adults. Once the toxin is produced, infants can experience symptoms like muscle weakness and, in more severe cases, breathing difficulties.
Infant Botulism Symptoms
In most cases, symptoms of infant botulism usually start showing within 18-36 hours of ingestion. The Mayo Clinic states that constipation is typically the first symptom, with other common symptoms being:
- Constipation, which is typically the first symptom
- Drooling
- Weak cry
- Drooping eyelids
- Paralysis
- Floppy movements
- Irritability
- Trouble feeding or sucking
- Loss of head control
While the majority of infant botulism cases start to show symptoms in the first 36 hours, symptoms can develop gradually and take several weeks to appear after exposure. If you think your child is a victim in the ByHeart infant formula recall case, schedule a free consultation with The Carlson Law Firm today.
Scope of the Infant Botulism Outbreak
If botulism goes untreated in infants, it can lead to a progressive paralysis that can affect their breathing and require weeks of care in the hospital. As of January 23, 2026, the Centers for Disease Control and Prevention (CDC) reports:
- 51 confirmed cases of infant botulism
- 51 hospitalizations
- No fatalities
Infant botulism cases have been reported in 19 states, including Texas and California. Health officials have stated that no new cases have been added since a Dember 10, 2025 update, but the investigation remains open.
Details of the ByHeart Infant Formula Recall
ByHeart Inc. issued a recall of all ByHeart Whole Nutrition Infant Formula products on November 11, 2025. This included all lot numbers, all can sizes and single-serve packets. The recalled formula was sold online and at major retailers nationwide.
Advice for parents and caregivers from the CDC is to:
- Wash and sanitize any items or surfaces that may have come into contact with the product
- Stop using the formula immediately
- Seek medical attention if an infant shows symptoms after consuming the formula
The Carlson Law Firm has experience with mass torts cases. Our legal team can evaluate the details of your case for potential pursuance of compensation.
What Investigators Have Found So Far
Reporting from PBS NewsHour and the Associated Press indicates that federal investigators traced contamination concerns to dried milk powder used in the formula. Key findings include:
- A sample of organic whole milk powder tested positive for Clostridium botulinum
- FDA testing found genetic matches between bacteria in milk powder samples, unopened cans of ByHeart formula and samples from sick infants
- The milk originated from Organic West Milk Inc. and was processed at a Dairy Farmers of America facility in Nevada
Officials from the companies involved have emphasized that the exact source and point of contamination have not been determined. ByHeart has recalled all products while the FDA’s investigation continues.
Medical Treatment and Reporting
Infant botulism is considered a medical emergency. If suspected, doctors may recommend treatment with BabyBIG, a botulism immune globulin. Health care providers are instructed not to wait for laboratory confirmation before beginning treatment when the child shows symptoms.
All suspected cases must be reported to state public health authorities. Parents who believe their child experienced an adverse reaction can also report concerns through the FDA’s Safety Reporting Portal, though medical care should come first if symptoms are present.
When a Product Liability Claim May Be Considered
Parents can have many legal questions when a consumer product intended for infants is linked to serious illness. Some popular questions may include:
- Whether warnings and safety measures were adequate
- Whether the product was contaminated
- Whether manufacturing or processing steps failed to prevent harm
Every situation is unique, and not every exposure results in a viable product liability claim. Families whose children were hospitalized or suffered complications after consuming recalled formula may wish to explore their legal options with The Carlson Law Firm.
ByHeart Infant Formula Recall FAQ
Why was ByHeart infant formula recalled?
The ByHeart infant formula recall followed an outbreak of infant botulism. Federal health officials found genetic matches between bacteria detected in recalled formula, milk powder used to make the formula and samples from sick infants.
What is infant botulism?
Infant botulism is a serious illness that occurs when Clostridium botulinum spores grow in a baby’s digestive system and produce a toxin that affects muscle control and breathing.
What symptoms should parents watch for?
Typical symptoms of infant botulism include:
- Constipation
- Poor feeding
- Difficulty swallowing
- Loss of head control
- Weak or altered crying
- Reduced facial expression
Most cases of infant botulism will begin to show symptoms within 36 hours, but symptoms may appear weeks after exposure.
What should I do if my baby consumed ByHeart formula?
Parents should stop using the recalled formula immediately and clean any items that touched it. Seek medical care if their baby shows symptoms. Medical providers can evaluate and begin treatment if necessary.
Are lawsuits being filed over the ByHeart infant formula recall?
The ByHeart infant formula recall and botulism outbreak have raised concerns over product safety. Families whose children were harmed may have legal options with a mass torts lawyer at The Carlson Law Firm depending on the facts of their situation and facts of the case.
Talk to a Mass Torts Attorney
The Carlson Law Firm is closely monitoring developments related to the ByHeart infant formula recall and the ongoing investigation into infant botulism cases. Families who believe their child was harmed after consuming the recalled formula may be eligible to pursue a claim, depending on the facts involved.
Talking to a mass torts attorney can help parents understand their rights and whether legal action may be appropriate. If you have questions or concerns, contact The Carlson Law Firm and schedule a free consultation to discuss whether legal action may be appropriate.
