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The families of two infants hospitalized with botulism are suing ByHeart, the organic baby-formula maker that <a href="https://www.ntd.com/infant-botulism-cases-linked-to-baby-formula-climbs-to-15-infants-in-12-states_1107067.html">recalled all its products</a> this week amid growing safety concerns.

Stephen and Yurany Dexter of Flagstaff, Arizona, said their 4-month-old daughter, Rose, had to be airlifted to a children’s hospital two hours away, where she spent several weeks undergoing treatment this summer.

Michael and Hanna Everett of Richmond, Kentucky, reported that their 4-month-old daughter, Piper, was hospitalized on Nov. 8 after her symptoms caused by the rare but potentially life-threatening illness rapidly worsened.

The lawsuits, filed in federal courts in Arizona and Kentucky, claim the ByHeart formula given to both children was defective. The suits accuse the New York-based company of negligence and seek compensation for medical expenses, emotional distress, and other damages. Both families stated they chose the organic formula, believing it was a safer alternative.

“I wouldn’t guess that a product designed for a helpless, developing human in the United States could cause something this severe,” said Stephen Dexter.

Hanna Everett said it was awful. “She’s so little and you’re just helplessly watching this,” she said.

Rose had received ByHeart formula days after her birth in July, after breast milk was insufficient, her father said. Stephen said he went to Whole Foods to find a “natural option.”

“I’m a little concerned with things that are in food that may cause problems,” he said. “We do our best to buy something that says it’s organic.”

Rose was healthy at birth, but didn’t thrive on the formula. She had trouble feeding and was fussy and fretful as she got sicker. On Aug. 31, when she was 8 weeks old, her parents couldn’t wake her.

Rose was flown by air ambulance to Phoenix Children’s Hospital, where she stayed for nearly two weeks.

Hanna Everett said she used ByHeart to supplement breastfeeding starting when Piper was 6 weeks old. “It’s supposed to be similar to breast milk,” she said.

Last weekend, Piper started showing signs of illness. Hanna said she became more worried when a friend told her ByHeart had recalled two lots of its Whole Nutrition Infant Formula. When a family member checked the empty cans, they found that they matched the recalled lots.

“I was like ... we need to go to the ER,” Hanna recalled.

At Kentucky Children’s Hospital, Piper’s condition worsened rapidly. Her pupils stopped dilating correctly, and she lost her gag reflex. Her head and arms became limp and floppy.

Doctors immediately ordered doses of the BabyBIG medication, which had to be shipped from California, Hanna said. Piper had to have a feeding tube and IV lines inserted.

In both cases, the babies improved after receiving treatment. Rose went home in September, and she no longer requires a feeding tube. Piper went home this week.

Both Rose and Piper received BabyBIG, the only treatment for infant botulism in children under 1 year old. The IV medication is derived from the plasma of adults who have been immunized against the neurotoxins that cause the illness.

Bill Marler, a Seattle food safety attorney who represents the Dexter family, said, “This company [ByHeart] potentially faces an existential crisis.”

ByHeart said in a statement it would address any legal claims in due course, and added, “We remain focused on ensuring that families using ByHeart products are aware of the recall and have factual information about steps they should take.”

A visit to the company’s website shows the recall information on the homepage. “We’re here with support—24/7,” it states, along with a phone number and a long list of frequently asked questions concerning the recalled infant formula.

“As parents ourselves, we understand how excruciating this recall has been. You deserve support, and our Parent Experience team is here to provide it—around the clock. You can speak with a person live, or leave your number and we’ll call you back,” it states.

According to a <a href="https://www.prnewswire.com/news-releases/byheart-celebrates-the-fda-registration-of-their-reading-pennsylvania-facility-becoming-the-first-new-infant-formula-manufacturer-in-the-us-in-over-15-years-301534863.html">press release</a> from the company in 2022, the company announced the FDA registration of its Reading, Pennsylvania, manufacturing facility, making it “only the 4th vertically integrated U.S. infant formula brand to have full oversight of their production, supply chain and R&D-enabling them to rewrite the formula recipe from scratch and have control over every step of the process, from farm to formula.” It stated that their infant formula was the first to include organic, grass-fed whole milk.

ByHeart also has formula <a href="https://www.prnewswire.com/news-releases/byheart-acquires-additional-domestic-infant-formula-manufacturing-facility-tripling-its-supply-capacity-and-continuing-to-fortify-formula-production-in-the-us-301729737.html">production</a> in Allerton, Iowa, and packing and blending production in Portland, Oregon.

The company issued a voluntary nationwide recall Tuesday, expanding on a smaller recall announced over the weekend for two contaminated lots of its Whole Nutrition Infant Formula.

The broader recall includes all ByHeart powdered formula sold online and at Target, Walmart, Whole Foods, Albertsons, and other retailers. ByHeart sells roughly 200,000 cans monthly.
<h2>84 Cases of Infant Botulism, 13 Linked to Formula</h2>
Both the company’s founder, Mia Funt, and its chief medical and scientific officer, Dr. Devon Kuehn, addressed the recall in separate videos on social media this past week.

Funt <a href="https://www.instagram.com/reel/DQ0hnKaDJIh/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA==">shared</a> that the FDA issued a broad investigation into infant botulism in the United States, as at least 84 cases have been identified since August, and that of those, 13 of the infants had their formula.

A day later, Dr. Kuehn <a href="https://www.instagram.com/reel/DQ5TOsrjEaq/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA==">shared</a> a video post, stating they “offered the FDA and CDC and California Department of Public Health full access to our facilities and unopened cans, without restriction. We are moving fast, and we are grateful for their collaboration. In addition, we are doing our expedited testing with an independent third-party facility and will share those results when they are available.”

“If your baby is experiencing any symptoms of infant botulism, such as constipation, poor feeding, weak cry, or muscle weakness, please seek medical attention immediately,” Dr. Kuehn posted.

The FDA’s <a href="https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025">latest update</a> on Tuesday announced an expanded recommendation to include all ByHeart infant formula products. The agency cited “the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested by the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP).”

According to the FDA, ByHeart infant formula products make up less than 1 percent of all infant formula sold in the United States. “This outbreak does not create shortage concerns of infant formula for parents and caregivers,” the FDA stated.

<em>The Associated Press contributed to this report. </em>

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