FDA opens investigation into ByHeart baby formula after 13 infants sickened with botulism
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Infants in 10 states, including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, have been hospitalized, totaling at least 13 cases.

SAN FRANCISCO — A multistate investigation into botulism has prompted health officials to caution against the use of certain batches of ByHeart baby formula.

The affected infants consumed the formula between August and November, leading to hospitalizations, as reported by the U.S. Food and Drug Administration. The states impacted are Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

Consumers are advised to steer clear of ByHeart Whole Nutrition Infant Formula with lot numbers 206VABP/251131P2 or 206VABP/251261P2, with an expiration date of December 1, 2026. These numbers are located at the base of the can.

ByHeart has opted for a voluntary recall of the implicated products, which were available both online and at major retailers across the nation. According to the FDA, this particular formula represents less than 1% of the total formula market in the U.S., and therefore, the recall is not expected to impact the overall supply.

The FDA urges people with these specific lots of baby formula to note the issue on the can then throw it away. 

No deaths have been reported at this time and the last documented illness was in November. An investigation into the outbreak is underway. 

Botulism is an illness caused by a toxin that attacks the body’s nerves. It can cause difficulty breathing, muscle paralysis and death in some cases. 

The FDA says infants with botulism may experience constipation, poor feeding, difficulty swallowing which can progress into difficulty breathing and possible respiratory arrest. Infants may also lose the ability to control their heads. 

Symptoms may take weeks to develop after getting botulism, according to the warning. 

Health officials encourage anyone with these symptoms, or who have infants experiencing these symptoms, to contact their health care provider. 

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