{"id":502,"date":"2026-06-16T17:07:56","date_gmt":"2026-06-16T17:07:56","guid":{"rendered":"https:\/\/smartmovinghome.com\/?p=502"},"modified":"2026-06-16T17:07:56","modified_gmt":"2026-06-16T17:07:56","slug":"for-second-time-in-7-months-baby-formula-linked-to-infant-botulism-is-recalled","status":"publish","type":"post","link":"https:\/\/smartmovinghome.com\/?p=502","title":{"rendered":"For Second Time in 7 Months, Baby Formula Linked to Infant Botulism Is Recalled"},"content":{"rendered":"
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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.<\/p>\n

Now Nara Organics, which has promoted the \u201cthousands of tests\u201d 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.<\/p>\n

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.<\/p>\n

The Nara Organics recall, which follows ByHeart\u2019s 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.<\/p>\n

\u201cTwo outbreaks in less than a year show that ByHeart was not a unique accident,\u201d said Sarah Sorscher, director of regulatory affairs at the Center for Science in the Public Interest, a consumer advocacy group.<\/p>\n

\u201cSomething is very wrong in the production of these formulas, and FDA is not moving fast enough to find the cause,\u201d Sorscher said. \u201cThe agency is currently conducting testing of milk ingredients, but that process is creeping along at a snail\u2019s pace and they still have no advice to offer on how to control these risks.\u201d<\/p>\n

Nara Organics says the recall, announced Saturday, is being done \u201cout of an abundance of caution\u201d 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.<\/p>\n

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 \u201cin the coming weeks,\u201d the CDC said.<\/p>\n

Nara Organics did not answer Healthbeat<\/em>\u2019s questions about the decision last fall to promote Nara\u2019s formula as the replacement for ByHeart\u2019s recalled formula during its infant botulism outbreak. Nara also didn\u2019t answer questions about whether the companies have any common suppliers or other relationships.<\/p>\n

In an email Monday afternoon, a ByHeart spokesperson said: \u201cByHeart and Nara Organics are completely separate companies. There is no corporate, financial, contractual, manufacturing, operational, or ownership relationship between ByHeart and Nara.\u201d<\/p>\n

ByHeart said it shared a Nara discount code as a resource to help its customers find alternative options quickly.<\/p>\n

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.<\/p>\n

ByHeart told Healthbeat<\/em> it removed the post \u201cfor safety considerations following the Nara news \u2013 while the offer is no longer valid, we did not want to take any chances.\u201d<\/p>\n

The source of the contamination of ByHeart\u2019s formula is still under investigation. The FDA has focused on ingredients supplied to the company, including a powdered milk ingredient.<\/p>\n

The agency said June 3 that while its inspections led to the identification of C. botulinum in a powdered milk ingredient, the agency \u201cdid not identify any additional factors within ByHeart\u2019s facilities that could explain the cause of this outbreak. FDA\u2019s root cause investigation is ongoing and will continue with a focus on ingredients.\u201d<\/p>\n

The FDA told Healthbeat<\/em> 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.<\/p>\n

\u201cLast year\u2019s 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,\u201d the FDA said in an email.<\/p>\n

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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.<\/p>\n

Nara Organics Formula Has Been on the Market Less Than a Year<\/h2>\n

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 \u201csetting a new standard that exceeds both U.S. and European safety requirements.\u201d<\/p>\n

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\u2019s website.<\/p>\n

The formula is manufactured in Germany from organic ingredients sourced from the United States and the European Union, according to the company.<\/p>\n

\u201cAt Nara, we run testing three times. On raw ingredients, on our formula powder as it\u2019s being made, and on our finished canned formula,\u201d the company\u2019s website says. \u201cFrom our first batch, we\u2019ve run voluntary screening for clostridia \u2013 a sign of bacteria that can cause botulism \u2013 and B. cereus, the organism that produces cereulide.\u201d Cereulide is a toxin that can cause nausea, vomiting, and dehydration in infants.<\/p>\n

Officials at Nara Organics did not answer questions from Healthbeat<\/em>, 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<\/em> the company had no comment beyond what was in its recall announcement.<\/p>\n

Over the years, some about the difficulty of testing for and detecting botulism spores in infant formula.<\/p>\n

Infants Hospitalized in California, Pennsylvania, Washington<\/h2>\n

The FDA told Healthbeat<\/em> that it first contacted Nara Organics on Wednesday, June 10, asking the company whether it had received any consumer complaints about infant botulism diagnoses.<\/p>\n

Then on Friday, June 12, the FDA said it contacted Nara Organics and recommended the company conduct a recall \u201cdue to the severity of illness and the epidemiological signal.\u201d The company, which said it was contacted \u201clate Friday,\u201d announced its recall on Saturday, June 13.<\/p>\n

According to the FDA, the three infants \u2013 who all had been fed Nara Organics-brand powdered infant formula \u2013 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.<\/p>\n

Leftover formula has been collected for testing in two of the states, the FDA said.<\/p>\n

The FDA told Healthbeat<\/em> 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. \u201cAt 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,\u201d the FDA said. No further details were provided.<\/p>\n

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 \u2013 labeling them as \u201cDO NOT USE\u201d \u2013 so that they can be tested should their child become ill.<\/p>\n

Because Nara Organics\u2019 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.<\/p>\n

Editor\u2019s note:<\/b><\/i> This story has been updated with responses from the FDA and ByHeart, which were sent after initial publication.<\/i><\/p>\n

Alison Young is Healthbeat<\/em>\u2019s senior national reporter. You can reach her at <\/i>ayoung@healthbeat.org<\/i>or through the messaging app <\/i>Signal<\/i>at alisonyoungreports.48<\/i><\/p>\n

Healthbeat is a nonprofit newsroom covering public health published by <\/em>Civic News Company and <\/em>KFF Health News. Sign up for their newsletters here.<\/p>\n

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