Powdered milk recalled due to botulism risk, also sold on Amazon
Il Ministry of Health has published a urgent notice regarding the withdrawal from the market of the ByHeart Whole Nutrition brand powdered milk, coming from the United States of AmericaThe product has been reported for a serious risk of botulism, after US health authorities linked infant formula to a case series of infant botulismThe alert has also been spread in Italy as the milk is found to be sold online through international platforms, among which Amazon.
The health alarm
According to the Ministry, the notice appeared on 19th November 2025 on the official food recall portal. The information, transmitted via the Internet Infosan (the international warning system coordinated by FAO and WHO), report 23 suspected and confirmed cases of infant botulism in 13 US states. All the children involved needed hospitalization. The company ByHeart Whole Nutrition has arranged All batches produced will be recalled on November 11th, but attention remains high for packages purchased online and shipped to other countries.
The international appeal
The Italian Ministry of Health has released the notification as a precautionary measure for avoid using ByHeart powdered milk in any format. The notice specifies that the product is also marketed through global e-commerce, with the risk that Italian families may have purchased it online. In the United States, the Food and Drug Administration (FDA) estimated that ByHeart represents approximately 1% of the infant formula marketThe withdrawal concerns all packages – both in can and universal sealed sachets – distributed until November.
The statements of the company
In an official statement, My Funt, co-founder and president of ByHeart, said the recall "reflects the company's commitment to protecting children and providing families with transparent and timely information." She also announced that the company is working with the FDA and with other health agencies to conduct thorough testing of unopened packages, in order to "provide reliable evidence and clarify the origin of the problem." The company reiterated that the safety of newborns remains the top priority and that a full investigation is underway.
Consumer advice
Il Italian Ministry of Health invite anyone who has purchased the ByHeart Whole Nutrition powdered milk – in any format or batch – a don't use it and Report possession of the product immediately to local health authoritiesConsumers who purchased it online can also Check for any notifications or communications received from retailers, like Amazon, which has already started a direct contact campaign with buyers.
The alert remains active internationally while case monitoring and supply analysis continue.
source: salute.gov.it