Stephen Dexter holds a container of ByHeart baby formula, which was recently recalled by ByHeart, in Flagstaff, Ariz., on Wednesday, Nov. 12, 2025. (AP Photo)
A growing health scare is unfolding across the United States as new test results suggest that all ByHeart infant formula products may be contaminated with botulism-causing bacteria. The finding has intensified concerns for parents and prompted renewed warnings from health officials.
Tests Reveal Broader Contamination Risk
Recent laboratory tests examined 36 samples from three different lots of ByHeart formula. Five samples tested positive for Clostridium botulinum type A, a rare but dangerous bacterium that can cause infant botulism.
The company released a statement confirming the results and admitted it “cannot rule out” contamination across all product lots. The discovery has raised alarms because this bacteria can be unevenly distributed, making it difficult to detect in powdered formula.
Dozens of Babies Sick Since August
At least 31 infants across 15 states have fallen ill since the outbreak began in August, according to state and federal health officials. Some babies who consumed the formula as far back as November 2024 were also treated for botulism, although those cases are not included in the current outbreak tally.
Doctors warn that infants under one year of age face the highest risk. Yet not every baby who consumes the contaminated powder will become sick, due to the patchy distribution of spores.
Recalled Products Still Found on Shelves
ByHeart initiated a nationwide recall on November 11. But despite the recall, some formula containers remained on store shelves, according to officials and the U.S. Food and Drug Administration.
Health authorities are urging parents and caregivers to stop using the product immediately and watch for symptoms, which may appear weeks after ingestion.
What Parents Should Look Out For
Infant botulism occurs when spores enter a baby’s gut and begin producing toxins. Early symptoms can be subtle but escalate quickly. Warning signs include:
- Constipation
- Poor sucking or feeding
- Drooping eyelids
- Reduced facial expression
- Weakness in the arms, legs, or head
Doctors emphasize that the condition is a medical emergency that needs prompt treatment.
Sharp Rise in Infant Botulism Treatments
Since August 1, at least 107 babies nationwide have received BabyBIG, an intravenous medication used to treat infant botulism. In a typical year, fewer than 200 infants require such treatment.
The recent spike has placed the outbreak among the most significant botulism-related events in recent years.
How to Report a Suspected Case
Parents who suspect a botulism case linked to ByHeart formula are advised to contact an FDA consumer complaint coordinator or report through the online MedWatch system. These reports help investigators track the spread and identify emerging risks.
Refunds Expanded for Affected Families
The company has expanded its refund policy in response to the crisis. Consumers who purchased ByHeart formula on or after August 1 through the company’s website are now eligible for a full refund.
As officials continue investigating the source and scale of contamination, they urge families to exercise caution. With symptoms sometimes taking up to 30 days to appear, continued monitoring remains essential for any child who consumed the recalled formula.
