ByHeart baby formula issued a response after the parents of at least two babies sickened in an infant botulism outbreak sued the makers of the formula at the heart of a nationwide recall.
The lawsuits, filed in federal courts in two states, allege that the ByHeart formula the babies consumed was defective and that the company was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.
Both families said they bought the organic formula to provide what they viewed as a natural, healthier alternative to traditional baby formulas, and that they were shocked and angered by the suffering their children endured.
In a statement sent to NBC 5 Responds, Mia Funt, ByHeart co-founder and president said, “our number one priority is infant health.”
“We express our deepest sympathy to the families currently impacted by the cases of infant botulism,” Funt said. “We are working with the FDA and independent experts to implement the recall quickly while the factual investigation continues. We are committed to getting answers—including partnering with the FDA and independent experts—and will share updates as soon as we can.”
The recall initiated amid a series of infant botulism cases potentially linked to powdered baby formula was expanded earlier this week.
According to a press release from the FDA, ByHeart expanded its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack products nationwide amid an investigation into at least 15 cases of infant botulism across the U.S.
All of the infants were hospitalized after consuming ByHeart formula, officials said. No deaths have been reported.
According to the FDA, two of those cases were reported in Illinois. Additional cases were reported in Minnesota and in Kentucky.
ByHeart had initially announced a voluntary recall of two batches of its Whole Nutrition Infant Formula following notification from the FDA of the cases, but the company has now expanded that recall to cover all batches of the product.
“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Funt at the time. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.”
The company in a statement said no unopened product has tested positive for Clostridium botulinum spores or toxin, and was done with the thought of “protecting babies above all else,” according to the FDA.
According to NBC News, the company sells about 200,000 cans of infant formula a month online and in stores like Target and Walmart.
The voluntary recall applies to the following:
- Can UPC: 85004496800
- Anywhere Pack (™) UPC: 85004496802
What Is Infant Botulism?
Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria. According to the FDA, symptoms may include:
- Constipation
- Poor feeding
- Drooping eyelids
- Sluggish pupils
- Low muscle tone
- Difficulty sucking or swallowing
- Weak or altered cry
- Generalized weakness
- Respiratory difficulty or arrest
The FDA warns that infant botulism can be fatal if not treated promptly.
Impact on Formula Supply
ByHeart’s formula accounts for less than 1% of all infant formula sold in the U.S., and the FDA says the recall is not expected to affect nationwide supply or contribute to a formula shortage.
Are Other Brands Involved?
Since August, the FDA has received 83 reports of botulism potentially tied to infant formula. NBC 5 has asked the agency for the names of other brands involved, but no additional information has been released.
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