Parents Are Furious About ByHeart’s Formula Recall
At the end of October, Fabio Luz noticed that his newborn son was suddenly having trouble swallowing and sucking from a bottle. At first, the baby’s pediatrician thought it was reflux, but as the days went on, the infant kept getting weaker. His body was floppy, and when he cried, he was so weak you could hardly hear him. After many tests at the hospital, doctors told Luz and his wife that they believed their son had infant botulism, a rare illness caused by bacterial spores that can lead to paralysis and trouble breathing and can be fatal. They were stunned. How could their 5-week-old have been exposed? “My wife and I are so cautious. We barely leave the house,” Luz says. “They were asking us if we gave him honey, which we didn’t.” A week later, ByHeart, the formula brand Luz’s son “drank from day one,” announced it was recalling certain batches of formula following an outbreak of infant botulism that had sickened at least 13 babies who had consumed it.
In a video posted to Instagram on Saturday, ByHeart co-founder Mia Funt emphasized that “there is no reason to believe that infant formula can cause infant botulism.” But a few days later, on Tuesday, the Food and Drug Administration asked ByHeart to expand the voluntary recall to include all of its formula products nationwide after two more babies got sick. While the investigation is ongoing, the California Department of Public Health has said that preliminary testing of ByHeart formula “indicated the presence” of the bacterial spores that cause botulism. Now, parents who have been using ByHeart are panicking — and many of them are livid at the company they trusted to feed their babies.
ByHeart — which launched in the thick of the nationwide formula shortage in 2022 — markets itself as a premium alternative to industry giants like Similac and Enfamil. Ads featuring Mandy Moore emphasized how close ByHeart’s “protein blend” is to breast milk, and its website played up the ingredients they didn’t use: no palm oil, no corn syrup, no GMOs. As MAHA fearmongered about seed oils, ByHeart touted the fact that its formula used organic, grass-fed whole milk — and less plant-based oils than other formulas. Chloe Coates, a mother of two in Kansas City, told me she chose ByHeart after extensive research. “I was literally comparing every single ingredient,” she says. “I thought it was the safest option.” Amy Snyder, a mother of six in California, says ByHeart ads were all over her feeds. She liked that the formula was made without palm oil: “It felt clean.”
But since the recalls were announced, ByHeart parents have been spiraling with anxiety. Marissa Russell was up late scrolling Facebook when she first saw the news — after her 4-month-old had just finished a can of ByHeart included in the initial recall: “I immediately panicked.” Russell’s pediatrician told her to go to the ER, though since her daughter wasn’t yet showing symptoms, the doctors said that all there was to do was wait. The illness can take weeks to develop. Katie Shanahan, a nurse practitioner in Massachusetts, has a 6-month-old with an airway disorder that causes difficulty with swallowing. Feeding was already a nightmare, she says, though her son had been doing well on ByHeart. “Now I have to monitor my child who already has medical needs for botulism?” she says. “It’s insane.” James Miller, a dad in Kansas, told me his newborn started ByHeart after being discharged from the NICU, just days before the recall. “We’re basically just staring at him now,” Miller says. “I don’t even want to put him down.”
According to the CDC, anything that came in contact with the formula — like bottles, bibs, and drying racks — should be sanitized with hot water and soap. But as parents bleach their kitchens and contemplate how to disinfect their Baby Brezzas, many feel that ByHeart isn’t taking the situation seriously enough. “There has been an absolute lack of urgency,” says Alex Covino, a mom in Massachusetts who, like many parents, found out about the recall on social media rather than from ByHeart directly. In a statement posted on Instagram, ByHeart said while its team is small, it was working 24/7 to help answer questions. But multiple parents told me that when they tried calling, the phone line was turned off. “It’s been radio silence,” Russell says. “It’s infuriating.” (As of Thursday, the line appears to be up and running, and ByHeart told The Cut it is “working as quickly and diligently as we can to respond to each inquiry.”) On Friday, ByHeart announced that it will refund up to two cans of formula purchased after October 1, 2025, though its customers weren’t impressed. Covino called the policy “beyond insulting,” adding, “We have 14 cans of formula on hand that have now been recalled.” ByHeart also posted a discount code for the recently launched bougie formula brand Nara Organics “to help support ByHeart families make a smooth transition to a new formula,” prompting many eye rolls. “As if I trust their recommendation on anything now,” says Miller.
This isn’t the first time that ByHeart has had a recall. Food Safety News reported this week that the company voluntarily recalled its formula in 2022 after a batch tested positive for Cronobacter — another bacteria that can be fatal to babies. The report also noted that the FDA sent ByHeart a letter warning about serious safety violations and unsanitary conditions at one of its manufacturing plants a year later. According to the New York Times, inspectors found mold in a water tank and hundreds of dead bugs in a food-production area. This was all news to the parents I spoke to. “I didn’t know that, as a parent, I needed to research my baby’s formula company and see if there’s warning letters from the FDA,” says Shanahan. “I feel embarrassed that I didn’t do enough research and just believed what I saw on social media,” says Snyder.
In a statement to The Cut, ByHeart said that the facility in question hasn’t been in commercial operation this year and was not involved in the current recall. It also stressed that the California Department of Public Health test that indicated its formula was contaminated was from “an opened partially used can,” and noted that “opened product can be contaminated after purchase from environmental sources.” The company said that it is “testing every batch of ByHeart formula with an independent accredited lab, as we work closely with the FDA and CDC on their own investigation.” The Times reports that two families whose babies were hospitalized with botulism filed lawsuits against ByHeart this week, claiming the company was negligent and that its formula was dangerous.
After more than a week in the hospital on a feeding tube, Luz says his son is slowly getting stronger. They’re hopeful he’ll be discharged next week, but even after that, he’ll likely need continued monitoring. When Luz left a comment on ByHeart’s Instagram feed about his family’s situation, he says the company messaged him asking for his number: “I never heard back from them.”
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