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The FDA says ByHeart infant formula has been recalled nationwide after 23 babies in 13 states were sickened with infant botulism.
PENNSYLVANIA – Federal health officials are urging parents in Pennsylvania and New Jersey to throw out all ByHeart Whole Nutrition Infant Formula after a nationwide recall tied to a growing outbreak of infantile botulism — a rare but potentially life-threatening illness.
The U.S. Food and Drug Administration said Friday that 23 babies across 13 states, including cases reported in Pennsylvania and New Jersey, have been hospitalized since August.
What we know:
The FDA says all the affected infants consumed ByHeart powdered formula. The manufacturer, a New York-based organic formula company, has recalled all of its products sold in the United States. Officials said laboratory testing in California detected the bacteria that cause botulism in an open can used to feed one of the sick infants.
The company produces its formula in Iowa and Oregon, and said it acted “in close collaboration” with the FDA out of an abundance of caution, even though no unopened cans have tested positive for contamination.
According to federal officials, ByHeart represents about 1% of the U.S. infant formula market, selling roughly 200,000 cans a month before the recall.
What parents should know
Health officials say symptoms of infant botulism can take up to 30 days to appear after exposure.Â
Parents should contact a pediatrician immediately if babies show:
Weak sucking or poor feedingDrooping eyelids or facial weaknessFloppiness or loss of head controlTrouble swallowing or breathing
So far, no deaths have been reported in the outbreak.
What is botulism?
Botulism is a rare but serious illness caused by a toxin produced by the bacterium Clostridium botulinum, which attacks the body’s nerves and can lead to muscle weakness, difficulty breathing and paralysis.Â
The spores of this bacterium are commonly found in soil and dust, and under certain conditions, such as when an infant’s gut is underdeveloped or when food is improperly processed in low-oxygen environments, they can germinate and release the toxin, according to the CDC. All suspected cases of botulism are considered medical emergencies because timely treatment is imperative.
How treatment works
All infants sickened in this outbreak have received BabyBIG, the only available antitoxin for infant botulism, made by the California Department of Public Health, according to reporting by the Associated Press. The treatment costs roughly $69,000 per dose and is given through an IV to neutralize the toxin.
What to do if you have ByHeart formula The FDA says anyone who purchased ByHeart Whole Nutrition Infant Formula should: Stop using it immediatelyCheck lot numbers and expiration dates on the company’s recall site or FDA’s databaseDispose of any opened or unopened cans safely
Consumers can contact ByHeart’s customer service or visit fda.gov for recall details and refund information.
Where cases have been reported
The outbreak has sickened infants in Arizona, California, Illinois, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
The FDA and Centers for Disease Control and Prevention continue to investigate and have not identified any other infant formula brands connected to the outbreak.
Local impact and context
Because ByHeart’s distribution includes major grocery chains and online retailers, officials warn that parents in Pennsylvania and New Jersey may still have recalled formula at home. Health departments in both states are assisting with outreach and urging families to double-check cans before feeding infants.
While ByHeart’s recall is broad, the company makes up a small portion of the U.S. formula market, so no national shortage is expected — a sharp contrast to the widespread shortages in 2022 following the Abbott Nutrition recall.
The Source: U.S. Food and Drug Administration, Associated Press Health reporting and the Centers for Disease Control and Prevention were sourced in this article.Â