A Pierce County couple has filed a federal lawsuit alleging their two-month-old daughter contracted botulism after consuming ByHeart infant formula, placing new attention on the company as state and federal health officials report that recalled cans of the formula were still being sold in some stores days after a nationwide recall.
The complaint, filed Wednesday in U.S. District Court of Western Washington, describes how the Eatonville infant experienced a sudden decline in early November after being fed ByHeart Whole Nutrition formula purchased at Target.
According to the lawsuit, the child developed constipation, difficulty feeding, choking, and extreme fatigue before being rushed to the emergency room on Nov. 13.
There, doctors determined she required immediate treatment for suspected botulism.
Hospital staff contacted federal and local health authorities after learning the formula had been recalled, the complaint states.
The baby received BabyBIG, the only available botulism antitoxin, after an overnight wait for it to be flown in from California.
A stool test performed the next day confirmed botulism.
In a statement included in the lawsuit, the child’s mother wrote from the hospital, “Knowing that I can’t fully feed my child, and I can’t trust formula companies has really taken a toll on our family.”
The lawsuit comes as federal officials report an ongoing multistate outbreak of infant botulism involving babies who consumed ByHeart formula.
At least 31 infants in 15 states have been hospitalized since August, according to the FDA and CDC.
Cases have been reported in Washington, Oregon, California, Texas, Minnesota and other states.
No deaths have been reported.
Infants involved in the outbreak range in age from about two weeks to six months old, and all have required hospitalization and treatment with BabyBIG, federal officials said.
Some cases remain under laboratory review.
Despite the nationwide recall, state officials in Oregon, Minnesota and Arizona told The Associated Press they found ByHeart formula for sale during inspections conducted a week after the recall began.
- Oregon inspectors visited more than 150 stores and found nine still selling ByHeart products.
- Minnesota conducted 119 checks between Nov. 13–17 and removed recalled cans from four locations.
- Arizona officials also reported locating the formula on shelves.
“No affected product should be sold or consumed,” Minnesota officials said in a statement.
Health departments are urging families to check their homes for ByHeart formula — including cans and single-serve sticks — mark them “DO NOT USE,” and keep them for at least a month in case illness occurs and testing is needed.
California health officials previously confirmed that an open can of ByHeart formula that had been fed to a sick infant contained the bacteria capable of producing the botulinum toxin.
Because detecting the organism in powder is difficult, federal officials say negative tests do not guarantee a product is safe.
The FDA has launched inspections at ByHeart’s manufacturing sites in Allerton, Iowa and Portland, Oregon. Results have not yet been released.
ByHeart said it issued its recall voluntarily “in close cooperation” with the FDA and noted that “no unopened ByHeart product has tested positive” for spores or toxin.
The lawsuit highlights earlier FDA inspections at ByHeart’s Reading, Pennsylvania facility, documenting problems found in 2023 and 2024, including:
- failures in production controls,
- unsanitary conditions,
- unresolved Cronobacter sakazakii findings in the processing environment,
- water leaks into manufacturing areas,
- and inadequate cleaning and monitoring procedures. botulism-3
Two of those inspections were classified “Official Action Indicated,” the FDA’s most serious warning before enforcement.
The parents accuse ByHeart of strict product liability, negligence, breach of warranty and negligence.
They claim the company sold a formula “contaminated with botulism spores” and failed to follow manufacturing standards designed to protect infants.
They are seeking damages for medical expenses, emotional distress, loss of enjoyment of life and other costs.
The family says their daughter continues to recover at home after her hospitalization.
The FDA, CDC and state health departments are continuing their investigation as recalled product removal efforts expand nationwide.