Botulism Concerns Trigger ByHeart Infant Formula Recall
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Nearly two dozen babies across the U.S. have been hospitalized in connection with a botulism outbreak linked to ByHeart infant formula.
California health officials reported early lab testing results showing possible botulinum-producing bacteria in an open can of ByHeart baby formula that was fed to an infant, according to the U.S. Food and Drug Administration. More testing is still being conducted on the powdered infant formula sold nationwide in stores and online.
Health officials urge parents and caregivers to stop using all ByHeart powdered infant formula, take photos or record the lot numbers and best by date, label it “do not use” and keep it stored in a safe place for at least a month.
So far, the FDA has identified 23 affected infants, ranging from 16 to 200 days old, from 13 states. Most infants were exposed to ByHeart formula and developed botulism illness between August 9 and November 11.
ByHeart initially recalled two batches of its infant formula on Nov. 8, and three days later broadened it to all products.
“We believe it is in the best interest of parents, caregivers, and public health for the FDA, CDC and other state public health agencies to conduct testing of unopened cans from the recalled batches at our facility,” ByHeart wrote in a letter to the FDA dated Nov. 10.
“Testing unopened cans will provide reliable evidence that will help bring clarity to families who are understandably concerned, as currently, no U.S. or imported formula is required to be tested for Clostridium botulinum.”
So far, no unopened ByHeart product has tested positive for botulinum spores or toxin.
What Is Infant Botulism?
Botulism is a rare and serious illness caused by a toxin that attacks the nervous system and can lead to breathing trouble, paralysis or death. The toxin is produced by Clostridium botulinum and a few related bacteria found in soil and dust.
According to the U.S. Centers for Disease Control and Prevention, infants with botulism can develop the following symptoms:
- Constipation
- Difficulty sucking and swallowing
- Low muscle tone
- Poor feeding
- Ptosis (drooping eyelid)
- Respiratory difficulty and possibly respiratory arrest
- Sluggish pupils
- Weak or altered cry
- Weakness
Symptoms can take several weeks to develop. Caregivers can wash items and surfaces that may have touched any ByHeart formula using hot soapy water or a dishwasher.
Two Families Sue ByHeart
The parents of two babies sickened in the botulism outbreak are suing the makers of ByHeart, claiming the company is directly responsible for their children’s illnesses, CBS News reported.
One lawsuit involves a 4-month-old girl from Arizona who was flown by air ambulance to a children’s hospital and treated for several weeks this summer. Another 4-month-old girl in Kentucky was hospitalized on Nov. 8.
“It was just absolutely terrifying,” Hanna Everett, of Kentucky, told CBS News. “You know, we just kind of felt like we failed as a parent in some ways.”
The lawsuits, filed in federal court, allege that ByHeart negligently sold a defective product. The families involved in the lawsuit wanted to use the formula as a “natural, healthier alternative to traditional baby formulas,” CBS reported.
ByHeart sells about 200,000 cans of formula a month, or about 1% of all formula sold in the U.S., the FDA told CBS.
Baby Formula Regulatory Action
This is not the first time ByHeart has been under scrutiny by the FDA. In late 2022, ByHeart voluntarily recalled its products due to potential cross-contamination with Cronobacter sakazakii, a bacterium that can cause sepsis or meningitis in infants.
That recall unfolded following a nationwide baby formula shortage driven by Cronobacter contamination at another manufacturer’s facility, which led to multiple infant illnesses and deaths. The crisis prompted the FDA to toughen oversight and introduce new safety requirements for all formula makers.
After inspecting ByHeart’s Pennsylvania plant, the FDA issued the company a warning letter in August 2023, citing major safety and sanitation violations, including Cronobacter contamination.
Separately, other formula manufacturers are facing hundreds of baby formula lawsuits over necrotizing enterocolitis (NEC) in infants who consumed cow’s-milk formula. The disease destroys intestinal tissue and can cause severe health complications or death.
What Steps Should Parents Take
Parents whose infants are experiencing symptoms related to botulism should contact a doctor immediately. They can also report an illness or adverse event by calling the FDA’s consumer complaint coordinator or filling out a Voluntary MedWatch form online. Parents can reach ByHeart on its 24-hour hotline at 1-833-429-4327 or by emailing hello@byheart.com.
Regarding its latest recall, ByHeart issued the following statement:
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, co-founder and president.
“We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. 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. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”