ByHeart recalls all baby formula sold nationwide as infant botulism
outbreak grows
[November 12, 2025]
By JONEL ALECCIA
ByHeart, a manufacturer of organic baby formula, recalled all of its
products sold nationwide Tuesday, days after some batches were recalled
in an expanding outbreak of infant botulism.
At least 15 babies in 12 states have been sickened in the outbreak since
August, with more cases pending, according to state and federal health
officials. All of the infants were hospitalized after consuming ByHeart
formula, officials said. No deaths have been reported.
ByHeart officials expanded the voluntary recall from two lots announced
Saturday to all products in consumers' homes and in stores. That
includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack
pouches of powdered formula. The company sells about 200,000 cans of
infant formula a month online and in stores such as Target, Walmart,
Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical
officer.
Parents and caregivers who have the formula in their homes “should
immediately discontinue use and dispose of the product,” Kuehn said.
Company officials said they enacted the unusual recall “in close
collaboration” with the U.S. Food and Drug Administration even though no
product that was previously unopened tested positive for the
contamination. The type of bacteria that produces the toxin is
widespread in the environment and could come from sources other than the
formula, company officials said.
“This action underscores ByHeart’s core mission: protecting babies above
all else,” the company said in a statement.
California health officials earlier confirmed that a sample from an open
can of ByHeart baby formula fed to an infant who got sick contained the
toxin-producing type of bacteria.
The U.S. Food and Drug Administration recommended that ByHeart expand
its recall because of the number of ill infants that reported consuming
the formula, the identification of additional lot codes, the growing
case count and the results of the California testing.
The FDA is investigating 84 cases of infant botulism detected since
August. Of those, 15 consumed ByHeart formula, the agency said in a
statement.
[to top of second column]
|
This undated image provided by ByHeart shows ByHeart formula
products.(ByHeart via AP)
 “This information shows that ByHeart
brand formula is disproportionately represented among sick infants
in this outbreak, especially given that ByHeart represents an
estimated 1% of all infant formula sales in the United States,” the
FDA statement said.
Illnesses began between Aug. 9 and Nov. 10, federal officials said.
Cases were reported in Arizona, California, Illinois, Kentucky,
Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode
Island, Texas and Washington.
Investigators have not identified any other infant formula brands or
other sources of exposure in the outbreak, officials said.
ByHeart produces formula powder at a plant in Allerton, Iowa, and
then ships it to a site in Portland, Oregon, for canning and
distribution, Kuehn said. U.S. Food and Drug Administration
inspectors were at the Portland plant Monday, she added.
In addition to the broad recall, the company said it is testing
every batch of formula with an independent third-party laboratory,
providing health officials full access to its sites and sharing
results with regulators as they become available.
Infant botulism is a rare and serious illness that occurs in babies
under age 1, whose gut microbiomes are immature. It is caused when
the infants consume bacteria that contain spores that produce a
toxin in the gut. Symptoms include constipation, poor feeding,
drooping eyelid, weak muscle tone, difficulty swallowing and
breathing problems, among others.
Babies who develop those symptoms need immediate medical attention.
The sole treatment for the infection is BabyBIG, an IV medication
made from blood plasma of people immunized against botulism.
All contents © copyright 2025 Associated Press. All rights reserved |
