Tuesday, 28 July 2026, 1:38
Public health authorities in California have confirmed a second case of infant botulism, bringing the national total to four infants sickened in a multistate outbreak tied to Nara Organics baby formula. The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are investigating alongside the California Department of Public Health (CDPH) and the Infant Botulism Treatment and Prevention Program (IBTPP). All four infants—two in California, one in Pennsylvania, and one in Washington—had consumed the recalled formula and were hospitalized. No fatalities have been reported. The illness onset dates range from April through May 2026, with the last illness onset on May 31, 2026. All four infants were confirmed to have toxin type A infections. The infants ranged in age from 2 to 5 months. Each of the infants was treated with an antitoxin produced and distributed by the state public health department, which shortens hospital stays and reduces the need for breathing machines. All four infants were treated with BabyBIG — the only FDA-approved treatment for infant botulism, available exclusively through the California Department of Public Health's Infant Botulism Treatment and Prevention Program (IBTPP). The four confirmed cases involve male infants who fell ill between April and May 2026. They ranged in age from approximately 68 to 153 days old at the time of illness onset, according to reporting from Food Safety Magazine. The three specific lots consumed by affected infants are lot codes 709125280E14F2, 709125288E14F2, and 708125174E14F2, according to Nara Organics' recall notice. However, given that the recall covers all lots, parents should not limit their concern to these lot numbers — any Nara Organics formula purchased during the distribution window should be treated as recalled. The Washington State Department of Health has confirmed a case in Thurston County.
Infant botulism occurs when a child under age 1 ingests bacterial spores that produce toxins in the intestines. Symptoms include constipation, drooping eyelids, weak muscle tone, difficulty swallowing, and trouble breathing. The CDC notes symptoms can appear weeks after exposure. Prompt treatment with an antitoxin produced by CDPH’s IBTPP can shorten hospital stays and reduce the need for mechanical ventilation. Most infants recover fully with timely care, but serious cases may require prolonged mechanical ventilation. Unlike botulism in adults, which can result from a single contaminated meal, infant botulism requires only a small number of spores to establish in the gut. That makes even trace contamination in a formula used repeatedly across weeks of feeding a potentially serious risk. Infant botulism is a rare but potentially fatal illness that occurs in babies — primarily those under 12 months of age — when Clostridium botulinum spores are ingested and produce a toxin inside the infant's immature digestive system. The toxin attacks the nervous system, causing progressive muscle weakness that can lead to breathing failure if untreated.
CDPH investigators detected Clostridium botulinum in an opened can of Nara formula taken from the home of one sick California infant. The FDA is testing unopened samples from the same lot numbers, with results expected in the coming weeks. The agency is also tracing the supply chain: the formula’s milk was supplied by Organic West Milk and spray-dried by Dairy Farmers of America—the same suppliers linked to a 2025 outbreak involving ByHeart formula. However, FDA says there is not yet enough evidence to confirm the contamination source. Notably, during the ByHeart investigation, Organic West Milk provided FDA with an incomplete customer list that did not disclose that it was also supplying milk to the manufacturers of Nara Organics formula. If FDA had been given a complete list, investigators might have examined Nara’s supply chain months earlier. The FDA investigation into the ByHeart outbreak was inconclusive. Testing of an unopened can from the same production lot is still underway; results are expected in the coming weeks, per the FDA.
California is at the epicenter of this outbreak, with two confirmed cases and the state health department leading critical testing. The CDPH’s IBTPP is the world’s sole provider of the infant botulism antitoxin BabyBIG, underscoring California’s central role in treatment and prevention. Parents across the state should be especially vigilant, as the formula was sold nationwide at Target stores and online.
This is at least the second infant botulism outbreak in the U.S. in 2026. Earlier this year, the FDA closed an investigation into ByHeart Whole Nutrition Infant Formula, which sickened 48 infants across 17 states. All were hospitalized, but no deaths were reported. The current outbreak shares suppliers with that incident, raising concerns about recurring contamination in the powdered formula supply chain. Prior to learning of the illnesses, FDA conducted inspections at 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. Nara Organics' formula is manufactured in Germany by Milchwerke Mittelelbe GmbH (Elb-Milch), a subsidiary of the Krüger Group. Two formula-linked botulism outbreaks within less than a year has raised urgent questions about manufacturing safety protocols and oversight across both domestic and international production facilities.
Back when the ByHeart recall was unfolding in late 2025, Nara Organics posted a page on its own website titled “Information for Families Affected by the ByHeart Recall.” The message to frightened parents looking for a safe alternative could not have been more confident: “Please be assured that Nara Organics is not affected by this recall and our formula is safe to drink. Your baby’s safety is our highest priority, and we hold ourselves to the most rigorous standards in the industry.” That page is still live as of July 2026. It told the very parents fleeing one botulism recall to come feed their babies a formula that would, months later, be pulled from shelves in its own botulism recall. This reassurance has been criticized as a marketing sentence rather than a food safety result, especially given that Nara’s page also boasted the formula was “made in Germany” by a partner with “over 70 years of experience.” None of that stopped C. botulinum from ending up in a can fed to an infant.
According to FDA’s June 26 update, the specific lots of Nara formula the sick infants consumed were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America (DFA). Those are the same two suppliers tied to the 2025 ByHeart infant formula botulism outbreak. The same milk source. The same spray dryer. A different brand on the label, but the same upstream ingredients flowing into babies’ bottles. FDA says that during the ByHeart investigation, Organic West Milk provided FDA with an incomplete customer list — a list that did not disclose that Organic West was also supplying milk to the manufacturers of Nara Organics formula. Regulators were investigating a deadly infant botulism outbreak. They asked who else was getting this milk. And they were not told about Nara. If FDA had been given a complete and accurate customer list in 2025, investigators might have been looking hard at Nara’s supply chain months earlier — before four more babies got sick. This is a supply-chain foreseeability problem: when the same milk and the same powder feed multiple brands, a contamination event is never really “one company’s problem.” It is a systemic problem.
Health officials urge parents to stop using Nara Organics formula immediately, discard or return unopened cans, and keep opened cans labeled “DO NOT USE” in case testing is needed. Watch infants for symptoms for at least a month after last use. If any signs appear—especially constipation, weakness, or breathing trouble—seek emergency medical care. The FDA and CDPH continue to investigate the root cause, and updates will be posted as they become available. Parents should also wash surfaces that came into contact with open cans with hot, soapy water. The IBTPP at the California Department of Public Health is available 24 hours a day, seven days a week, for physician case consultation at 510-231-7600. The FDA issued a direct warning in connection with the July 6 update: "Parents and caregivers should stop using Nara Organics Whole Milk Organic Infant Formula immediately," the agency stated. "If your child is experiencing symptoms after consuming Nara Organics Whole Milk Organic Infant Formula, seek immediate health care." The CDC has stated clearly that botulism can be fatal and that any parent whose infant consumed the recalled formula and is showing symptoms should seek emergency care before contacting health authorities. Dr. Wendy Schuchat, who has advised on prior infant botulism investigations, has noted that the rarity of this condition makes rapid recognition by parents and pediatricians critically important. "Infant botulism often starts with what looks like constipation or a tired baby — but it can escalate quickly," she has said in previous guidance contexts. "Delayed recognition is the most dangerous factor."
