ByHeart recalled two lots of its Whole Nutrition Infant Formula after 13 infants were hospitalized with botulism, according to the FDA.
SAN FRANCISCO — Health experts warned against feeding specific lots of ByHeart baby formula to children as they opened a multistate botulism investigation Saturday.
At least 13 infants have been hospitalized in 10 different states — Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington — after consuming the formula between August and November, according to the U.S. Food and Drug Administration.
No deaths have been reported at this time and the last documented illness was in November. ByHeart says they were notified Friday about 83 cases of infant botulism reported nationwide since August. An investigation into the outbreak is underway.
The warning advises people not to use ByHeart Whole Nutrition Infant Formula with lot numbers 206VABP/251131P2 or 206VABP/251261P2, both with a use by date of Dec. 1, 2026. The numbers can be found on the bottom on the can.
ByHeart agreed to voluntarily recall the products, which were sold online and at major retailers nationwide. The FDA says this formula makes up less than 1% of all formula sold in the U.S. and the recall should not create shortage concerns.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” Mia Funt, Co-Founder and President said in a statement. “This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents.”
All 13 hospitalization cases included in this outbreak are reported to have consumed ByHeart- brand powdered infant formula, according to the FDA alert.
The FDA urges people with these specific lots of baby formula to note the issue on the can then throw it away.
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.
