Tests of ByHeart infant formula reveal a serious health risk linked to a botulism outbreak that has affected infants across 15 states. Laboratory results show that out of 36 samples tested from three product lots, five contained the bacteria capable of causing this dangerous illness.
The company announced on its website that we cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated. As a result, authorities are urging parents to refrain from using any ByHeart products and monitor infants for symptoms, which may take up to 30 days to display.
As of now, at least 31 infants have fallen ill due to the formula, with numbers highlighting cases dating back to November 2024, which are not included in the current outbreak tally. Medical experts warn that Clostridium botulinum type A, the bacteria detected, is capable of uneven distribution in powdered formula, making every infant under one year susceptible to illness upon ingestion.
The FDA, alongside state officials, has commented on the persistent presence of recalled products still sitting on store shelves. Parents are encouraged to report any linked illnesses to the FDA or utilize their online reporting system.
This outbreak has led to a national call for increased awareness and preventive measures, as typically under 200 infants nationwide are treated for botulism annually. ByHeart, in response to these alarming findings, offers refunds for purchases made after August 1st on their website.



















