Infant Botulism and Baby Formula
Introduction and key points
Recent infant botulism outbreaks have been related to baby powder formulas contaminated with Clostridium botulinum. Most recently, Nara Organics issued a nationwide voluntary recall of all its powdered infant formula sold at Target and online, following an outbreak of three infant botulism cases across multiple states. The specific products recalled were sold nationwide in Target stores, Target.com, and Nara.com between July 2025 and June 2026. The three infants were fed Nara Organics Whole Milk Organic Infant Formula, a powdered infant formula. Federal agencies, including the FDA and CDC, have mandated or advised the removal and immediate cessation of all lots of this formula.
The FDA stated that Nara Organics Whole Milk Organic Infant Formula accounts for less than 1% of all infant formula sold in the US; as a result, the outbreak does not pose a shortage concern for parents and caregivers.
In 2025, ByHeart recalled all of its powdered infant formula after testing revealed Clostridium botulinum in product and ingredient samples.
The ByHeart Outbreak
From late 2025 through early 2026, the FDA and CDC, in collaboration with the California Department of Public Health (CDPH) ‘s Infant Botulism Treatment and Prevention Program (IBTPP) and other state and local partners, investigated a multistate outbreak of infant botulism. In total, 48 infants became ill across 17 states. On February 26, 2026, the CDC declared the outbreak over, and the FDA’s inspections at the ByHeart facilities also concluded.
The FDA reported that, as part of its investigation, it has completed its on-site inspections of ByHeart facilities. These inspections led to the identification of Clostridium botulinum in a powdered milk ingredient. These inspections 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.
A problem discovered during the recall was that retailers didn’t pull ByHeart baby formula fast enough after the botulism recall, the FDA says. Four of the nation’s top retail stores failed to promptly pull contaminated infant formula tied to the dangerous botulism outbreak from their shelves, federal health officials said in warning letters. The FDA sent letters to leaders at Walmart, Target, Kroger, and Albertsons, saying the companies continued to sell ByHeart infant formula for days or weeks after a November 11 recall of all products linked to an outbreak that has sickened more than 50 babies in 19 states.
The formula was found at Target stores in 20 states “well after the recall was initiated,” one letter said. In addition, it was sold at a Target store in New Hampshire on November 16, despite an electronic block on the product’s sales code, the FDA noted. And at a Target store in Arkansas, single-serve packs of ByHeart formula were promoted with a “Sale!” sign and a $2 discount from November 16 to November 22.
Information from state and local health officials said ByHeart formula was found at Walmart stores in 21 states from November 12 to November 26. The formula was found in Albertsons stores in 11 states from November 12 to November 19, and in Kroger stores in 10 states during the same period.
ByHeart failed to provide the FDA with evidence that corrective actions have been put in place, despite multiple requests, the agency said.
All of the babies in the outbreak have been hospitalized and treated with an IV medication to stop the progression of the disease. The CDC expanded the outbreak to include all babies treated for botulism after consuming ByHeart formula since it was first produced in 2023.
Steven Mandernach, executive director at the Association of Food and Drug Officials, said the FDA itself was slow to distribute information about the recall to state and local food safety officials. The agency didn’t fully share product lists until November 14, nearly a week after the initial recall of two lots of ByHeart formula on November 8. “There probably wasn’t the sense of urgency to ensure the product was off the market that I would expect,” Mandernach said.
The Nara outbreak
CDC, FDA, the Infant Botulism Treatment and Prevention Program, and public health officials in several states are investigating a multistate outbreak of infant botulism linked to recalled powdered infant formula. As of June 13, 2026, 3 infants with confirmed or suspected infant botulism have been reported from 3 states: California (1), Pennsylvania (1), and Washington (1). Illnesses started in April through May 2026. All 3 infants were hospitalized and treated with BabyBIG. No deaths have been reported. On June 13, 2026, Nara Organics recalled all of its infant formula. Nara Organics infant formula is a powdered formula sold at Target retail stores, Target.com, and Nara.com. This brand of formula accounts for less than 1% of all infant formula available in the United States, and shortages resulting from this recall are not expected.
Nara Organics whole milk powdered infant formula was manufactured in Europe. Specifically, it was produced by the German company Milchwerke Mittelelbe GmbH (Elb-Milch), which is a subsidiary of the Krüger Group. Milchwerke Mittelelbe GmbH manufactured the powdered infant formula in bulk and shipped it to a facility in Denmark operated by Advanced Nordic Nutrition (ANN, formerly Fipros Nutrition ApS) for final packaging.
The safety of infant formula
A major problem with the infant formula industry is that only a few companies (Abbott, Mead Johnson, and Perrigo) dominate 90% of the US market. That exacerbates both the potential reach of food safety issues and the risk of shortages, as was the case in 2022 with the devastating shortage following Abbott recalls.
So experts in infant nutrition generally support getting new entrants into a highly concentrated field. Along with ByHeart and Nara, the past few years have ushered in competitors like Bobbie, the European brand Kendamil, and, most recently, Little Spoon, all geared toward upscale, health-conscious parents, the type likely to frequent farmers markets and scrutinize ingredient lists on food packaging.
By Heart Whole Nutrition and Nara Organic Whole Milk Infant Formula are small manufacturers of infant formula. Until these two outbreaks, C. botulinum had not been considered a hazard in powdered infant formula. But with two high-profile outbreaks of infant botulism linked to similar products, whole milk powder-based formulas are being marketed as organic ingredients. The question is how to prevent future outbreaks.
Significantly, both Nara and ByHeart sought to differentiate their products by using organic whole milk powder rather than the usual nonfat milk powder prevalent in the US.
There is also a lack of standards for testing for C. botulinum spores in the product.
A group of experts on a joint committee of the World Health Organization and the Food and Agriculture Organization is currently conducting a risk assessment of spore-forming pathogens, such as C. botulinum, in infant formula. Currently, it’s “a huge problem that the FDA doesn’t have any guidance yet for industry on how to prevent this risk.
Dr. Frank Yiannas noted that unlike liquid formula, powdered infant formula is not sterile. This puts parents worried about the possibility of botulism in a hard place. But if exclusive breastfeeding or liquid formulas aren’t options, is powdered formula the only option?
With 2/3 of babies in the US consuming some formula in their first year of life, infants who fall sick are extremely rare.
Another such baby sat on the floor of a London apartment one recent afternoon, playing with his mom, Anit Joseph. At 9 months old, his dark hair fell in a fringe across his forehead, and he bounced on her lap with his mouth open in gummy delight.
The ByHeart outbreak brought the issue of C. botulium contamination in powdered infant formula into the spotlight. The new Nara outbreak further underscores the need to reconsider C. botulinum as a hazard in formula production processes. A study published in Frontiers in Microbiology conducted by IEH suggested that the use of sulfite-reducing clostridia (SRC) enumeration, which is recommended as a general indicator of spore contamination by the International Commission on Microbiological Specifications for Foods (ICMSF), may not be enough to ensure powdered infant formula is free of C. botulinum. The authors concluded that “indicator-based screening (such as SRC enumeration) would not have prevented C. botulinum occurrence. In the absence of any other method, some Companies are using SRC as an indicator for C. botulinum despite its inefficiency.
Unfortunately, SRC testing was also in place at Nara Organics before the outbreak. Nara had a specification that is 10 times the international best practice recommended by ICMSF, which set a maximum level of less than 100 colony-forming units per gram (CFU/g). Nara set its specification at less than 10 CFU/g. The company went so far as to test each batch of formula for SRC at three stages (i.e., raw ingredients, formula powder during production, and finished packaged product). To date, the root cause of the outbreak in both companies is unknown. Neither the companies nor the FDA was able to pinpoint the root cause of the contamination.
Regardless, C. botulinum should be considered a hazard in infant formula. As Frank Yiannas declared, “While it may represent a low-frequency, high-severity risk, the consequences are simply too great to ignore. The focus now should be to urgently identify root causes, strengthen science-based preventive controls, and supply chain oversight to better protect our most vulnerable consumers—infants.”
While US infant formula is generally safe, the ByHeart outbreak caused a shortage of product. However, the problem of C. botulinum in baby formula remains unsolved.