Washington, D.C. – ByHeart, the U.S. infant formula
manufacturer, announced a complete and voluntary recall of all its products
after health authorities detected a possible outbreak of infant botulism
allegedly linked to one of its powdered formula batches.
According to a statement issued by the company, the decision
was made “out of an abundance of caution and in cooperation with the U.S. Food
and Drug Administration (FDA)” after several cases of botulism poisoning were
confirmed in infants who consumed the formula in recent weeks.
The FDA and the Centers for Disease Control and Prevention
(CDC) are investigating the source of the outbreak and are urging parents and
caregivers to immediately discontinue use of any ByHeart product, regardless of
the batch number or expiration date.
Health authorities warned that infant botulism is a serious
illness caused by the bacterium Clostridium botulinum, whose toxins can cause
muscle paralysis, respiratory distress, and, in severe cases, death. Initial
symptoms include constipation, general weakness, weak crying, and feeding difficulties.
“The risk is low, but potentially fatal. That’s why we are
acting with the utmost caution,” the FDA stated in its emergency advisory.
The Pennsylvania-based company affirmed that it maintains
the highest production standards, although it acknowledged possible
deficiencies in the microbiological control of one of the batches manufactured
at its plant during the past month.
In a message released through its official social media
channels, ByHeart stated that it is cooperating closely with authorities and
offered full refunds to affected consumers. “Our absolute priority is the
health and safety of babies and their families,” the company stated.