Parents and guardians should immediately stop using ByHeart Whole Nutrition Infant Formula.
This additional case has not yet been added to CDC numbers.
A Pierce County infant was diagnosed Nov. 13, 2025, with suspected infant botulism. The infant is being treated at a local hospital. The infant reportedly consumed formula that has now been linked to a national outbreak of infant botulism. Washington State Department of Health will coordinate testing to confirm the diagnosis.
On Nov. 8, 2025, Centers for Disease Control and Prevention announced an outbreak of infant botulism linked to infant formula. Since August 2025, at least 23 cases have been identified in 13 states, including 1 case in an infant who resided in Lewis County at the time of exposure.
Although infant botulism is potentially fatal, no deaths have been reported in this outbreak so far. Several infants remain hospitalized.
On Nov. 11, 2025, the Food and Drug Administration recalled all lots of ByHeart Whole Nutrition Infant Formula sold in 24 oz. cans and 0.6 oz. “anywhere” single-serving packets.
Infant botulism is a rare illness that causes symptoms like constipation, poor feeding, loss of muscle tone, and a weak or altered cry. If untreated, the condition can lead to paralysis, trouble breathing, and death. Symptoms of infant botulism can take several weeks to develop.
“If your child consumed this formula and later develops symptoms of botulism, please contact your healthcare provider immediately or seek emergency care,” said Dr. James Miller, Tacoma-Pierce County Health Officer. “We do not know of any cases linked to other brands of infant formula.”
Parents and guardians should immediately stop using ByHeart Whole Nutrition Infant Formula, including unopened 24 oz. cans and 0.6 oz. single-serving packets. Keep the formula for a month, label “DO NOT USE” and record lot numbers of opened formula that infants consumed. We recommend keeping the formula for a month in case public health needs to test the formula. Wash items and surfaces that may have touched the recalled formula using hot soapy water or a dishwasher.
Washington has an average of 4 cases of infant botulism every year. Most affected infants are 6 months or younger, although cases can occur until the child’s first birthday.