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When ByHeart infant formula was linked to a nationwide outbreak of infant botulism last fall, the company encouraged its customers to switch to another premium whole milk formula made by Nara Organics.
Now Nara Organics, which has promoted the “thousands of tests” it runs on every formula batch, is recalling all of its whole milk organic powdered infant formula after the Centers for Disease Control and Prevention linked it to three babies being hospitalized with infant botulism.
The CDC and the U.S. Food and Drug Administration are urging parents and caregivers to immediately stop using Nara Organics Whole Milk Organic Infant formula, which is sold at Target and online. Parents should seek immediate care for their infant if they have symptoms such as poor feeding, loss of head control, difficult swallowing, or decreased facial expression.
The Nara Organics recall, which follows ByHeart’s recall in November, marks the second time in seven months that a premium organic whole milk infant formula has been linked to an outbreak of infant botulism. The recalls have fueled concerns among parents about the safety of infant formula and the effectiveness of federal oversight.
“Two outbreaks in less than a year show that ByHeart was not a unique accident,” said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, a consumer advocacy group.
“Something is very wrong in the production of these formulas, and FDA is not moving fast enough to find the cause,” Sorscher said. “The agency is currently conducting testing of milk ingredients, but that process is creeping along at a snail’s pace and they still have no advice to offer on how to control these risks.”
Nara Organics says the recall, announced Saturday, is being done “out of an abundance of caution” because of the risk that its formula is contaminated with Clostridium botulinum bacteria spores, which cause infant botulism. It can take several weeks between when a child consumes the spores and when they start showing signs of illness. If not treated, infant botulism can lead to paralysis and death.
The company said its infant formula has not tested positive for C. botulinum. The CDC said testing is underway of opened cans of Nara Organics formula and unopened product samples from the company. Results are expected “in the coming weeks,” the CDC said.
Nara Organics did not answer Healthbeat’s questions about the decision last fall to promote Nara’s formula as the replacement for ByHeart’s recalled formula during its infant botulism outbreak. Nara also didn’t answer questions about whether the companies have any common suppliers or other relationships.
In an email Monday afternoon, a ByHeart spokesperson said: “ByHeart and Nara Organics are completely separate companies. There is no corporate, financial, contractual, manufacturing, operational, or ownership relationship between ByHeart and Nara.”
ByHeart said it shared a Nara discount code as a resource to help its customers find alternative options quickly.
A ByHeart post on Instagram from Nov. 11 that recommended Nara Organics products and offered a 20% off discount code was deleted Monday after Healthbeat shared the link with both companies. An archived image of the post is available here.
ByHeart told Healthbeat it removed the post “for safety considerations following the Nara news – while the offer is no longer valid, we did not want to take any chances.”
The source of the contamination of ByHeart’s formula is still under investigation. The FDA has focused on ingredients supplied to the company, including a powdered milk ingredient.
The agency said June 3 that while its inspections led to the identification of C. botulinum in a powdered milk ingredient, the agency “did not identify any additional factors within ByHeart’s facilities that could explain the cause of this outbreak. FDA’s root cause investigation is ongoing and will continue with a focus on ingredients.”
The FDA told Healthbeat it is working with experts around the world to understand the risks of C. botulinum in infant formula to inform future monitoring and control measures.
“Last year’s outbreak involving ByHeart powdered infant formula was the first botulism outbreak definitively tied to infant formula anywhere in the world since infant botulism was first described as a distinct clinical entity almost 50 years ago,” the FDA said in an email.
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Health and Human Services Secretary Robert F. Kennedy Jr. last year launched an infant formula initiative called Operation Stork Speed, which initially focused on formula nutrients and testing for pesticides, heavy metals, and per- and polyfluoroalkyl substances, or PFAS. In February, in response to the ByHeart recall and infant botulism outbreak, the FDA said it was beginning a sampling project focused on dairy-based ingredients that includes looking for C. botulinum.
Nara Organics Formula Has Been on the Market Less Than a Year
Nara Organics launched its infant formula last July, touting celebrity investors such as Serena Williams, Gina Rodriguez, and Nicky Hilton, and saying the company was “setting a new standard that exceeds both U.S. and European safety requirements.”
After initially being sold online, in January, the company announced its first retail launch, which put the product on the shelves of more than 1,800 Target stores nationwide, as well as on the retailer’s website.
The formula is manufactured in Germany from organic ingredients sourced from the United States and the European Union, according to the company.
“At Nara, we run testing three times. On raw ingredients, on our formula powder as it’s being made, and on our finished canned formula,” the company’s website says. “From our first batch, we’ve run voluntary screening for clostridia – a sign of bacteria that can cause botulism – and B. cereus, the organism that produces cereulide.” Cereulide is a toxin that can cause nausea, vomiting, and dehydration in infants.
Officials at Nara Organics did not answer questions from Healthbeat, including about its microbial safety testing and whether its testing methods and protocols are sufficient to ensure botulism bacteria spores are not present in formula sold to consumers. A Nara spokesperson told Healthbeat the company had no comment beyond what was in its recall announcement.
Over the years, some about the difficulty of testing for and detecting botulism spores in infant formula.
Infants Hospitalized in California, Pennsylvania, Washington
The FDA told Healthbeat that it first contacted Nara Organics on Wednesday, June 10, asking the company whether it had received any consumer complaints about infant botulism diagnoses.
Then on Friday, June 12, the FDA said it contacted Nara Organics and recommended the company conduct a recall “due to the severity of illness and the epidemiological signal.” The company, which said it was contacted “late Friday,” announced its recall on Saturday, June 13.
According to the FDA, the three infants – who all had been fed Nara Organics-brand powdered infant formula – fell ill between April and May. All required hospitalization. The last date of illness onset was May 31. The infants, who ranged in age from 2-months-old to 5-months-old, were in California, Pennsylvania, and Washington state.
Leftover formula has been collected for testing in two of the states, the FDA said.
The FDA told Healthbeat that before it was aware of the infant botulism cases, the agency inspected the two firms that manufacture Nara Organics Whole Milk Organic Infant Formula in Europe. “At the conclusion of both inspections, observations citing deficiencies were issued to both facilities. Both firms have submitted corrective action responses to FDA, which are currently under review,” the FDA said. No further details were provided.
The FDA is warning consumers to not use any Nara Organics Whole Milk Organic Powdered Infant Formula. But the agency is suggesting parents and caregivers consider holding onto any opened formula containers for a month – labeling them as “DO NOT USE” – so that they can be tested should their child become ill.
Because Nara Organics’ formula makes up less than 1% of the infant formula sold nationwide, there is not a risk of the recall and outbreak causing concerns about shortages.
Editor’s note: This story has been updated with responses from the FDA and ByHeart, which were sent after initial publication.
Alison Young is Healthbeat’s senior national reporter. You can reach her at [email protected]or through the messaging app Signalat alisonyoungreports.48
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