It seemed like one of those pieces of news that only concerns those who live overseas. But no: ByHeart Whole Nutrition infant formula, at the center of a serious outbreak of infant botulism in the United States, may also have been purchased by Italian consumers via Amazon.com. The Ministry of Health launched the alert, inviting anyone who bought the product online to be extremely cautious.
It all started between August and November 2025. Several American newborns, some as young as two weeks old, began to show disturbing symptoms: difficulty feeding, progressive muscle weakness, loss of head control, crying weaker than usual. Signs that doctors have recognized as compatible with infant botulism, a rare but extremely dangerous disease.
The first data spoke of 13 children hospitalized in 10 American states. Today the toll is more serious: according to the update of the INFOSAN Emergency system (the global alert system for food safety), the suspected and confirmed cases have risen to 23 newborns, distributed in 13 different states, all requiring hospitalization.
Investigations by the FDA (Food and Drug Administration) and the CDC (Centers for Disease Control and Prevention) identified a common element: all the affected children had consumed ByHeart Whole Nutrition infant formula. Initially only two specific batches were under investigation, but US authorities now fear that all batches may be contaminated, increasing the severity of the alert.
The recall in the United States
On November 11, 2025, ByHeart Inc. began recalling all lots of its baby formula, no longer just the two initially suspected. The company announced that the product was sold mainly online through various platforms, including Amazon, and that American customers were notified directly by the retailer.
The American health authorities have given precise instructions: every bottle, teat or surface that has come into contact with the recalled milk must be washed carefully with hot water and soap. And above all, maximum vigilance over the symptoms.
The investigation is still ongoing and many questions remain open. Where exactly did the contamination occur? At what stage of production? Why do authorities now suspect that all lots may be at risk, not just two specific ones?
US authorities are analyzing milk samples collected from the homes of affected families, but final results are not yet available. In the meantime, there is only one recommendation: maximum caution.
The alert also reaches Italy: the product was on Amazon
The Italian Ministry of Health, through the INFOSAN Emergency contact point, has published an official notice aimed at Italian consumers.
Although ByHeart Whole Nutrition is not officially distributed in our country through traditional channels, the product may have been purchased by Italian families via Amazon.com and may still be found in some homes.
The Ministry’s statement is clear: since the US authorities fear that all batches may be contaminated and cause infant botulism, anyone who has purchased this infant formula must immediately stop using it, regardless of the batch number.
What is infant botulism and why is it so scary
Infant botulism is caused by spores of the bacterium Clostridium botulinum. When these spores colonize the still immature intestine of the newborn, they produce a very powerful toxin that causes progressive muscle paralysis, compromising the ability to feed, breathe and move independently.
What makes this story even more alarming is that there is no precedent for infant botulism outbreaks linked to commercial formula in the United States. It is an unprecedented event that raises important questions about the safety of children’s products and the effectiveness of quality controls throughout the production chain.
Another critical aspect is the fact that symptoms can appear even several weeks after consuming the contaminated milk, making it difficult for parents to immediately link the child’s illness to the product.
