--- title: Nara Organics Infant Formula Botulism Outbreak Lawsuits date: 2026-06-13T19:15:00-07:00 author: Bill Marler canonical_url: "https://marlerclark.com/the-ten-largest-foodborne-illness-outbreaks-in-the-u-s-since-1993-and-marler-clarks-role-in-them" section: Litigation Landing Pages --- [Foodborne Illnesses](/foodborne-illnesses) / [Botulism](https://marlerclark.com/foodborne-illnesses/botulism) / # Nara Organics Infant Formula Botulism Outbreak Lawsuits **Nara Organics Infant Formula Botulism Outbreak Lawsuits** ***Marler Clark represents two of the four families whose infants were sickened in this outbreak. Complaints are on file in federal court in Pennsylvania and in Washington.*** - • **Product:** Nara Organics Whole Milk Organic Powdered Infant Formula, 700g (UPC 860013251901) and 400g (UPC 860013251918), manufactured in Germany - • **Sold:** Target retail stores, Target.com and Nara.com, July 2025 through June 2026; not distributed outside the United States - • **Cases:** 4 confirmed infant botulism cases, toxin type A - • **Hospitalizations:** 4, all treated with BabyBIG - • **Deaths:** 0 - • **Locations:** California (2), Pennsylvania (1), Washington (1) - • **Illness onsets:** April 20, May 17, May 20 and May 31, 2026 - • **Recall:** June 13, 2026 — all sixteen lots then on the market - • **Status:** CDC declared the outbreak over on August 27, 2026; FDA’s root cause investigation remains open **The second infant formula botulism outbreak ever recorded, seven months after the first** Infant botulism is normally sporadic: one baby, one household, and no identified commercial source. Spores are common in soil and dust, and most infants who get sick are never traced to a product at all. A multistate outbreak tied to a manufactured infant formula is a different thing, and until 2025 it had never happened. FDA has stated that the [November 2025 ByHeart outbreak](https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025) was the first botulism outbreak tied to infant formula anywhere since the condition was first described about fifty years ago. The Nara Organics outbreak is the second. It followed the first by seven months, and it is the first in which whole genome sequencing has tied an infant fed one brand of formula to sealed cans of a different brand, through the dairy ingredient the two brands shared. Fifty-two infants were hospitalized across the two outbreaks. **How the outbreak surfaced** Late on Friday, June 12, 2026, FDA and CDC told Nara Organics that three infants in California, Washington and Pennsylvania had been hospitalized with infant botulism and treated with BabyBIG after being fed Nara formula. The three lots those infants were fed were 709125280E14F2, 709125288E14F2 and 708125174E14F2. The next day Nara [recalled all sixteen lot codes](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk) then on the market — every can it had sold through Target and its own website since July 2025 — while stating that Nara formula had not tested positive for *C. botulinum*. Within four weeks, CDC reported that it had. On July 6, 2026 the agency added a fourth case and reported that laboratory testing had detected *C. botulinum* in an open can of Nara formula fed to one of the infants. **What the agencies concluded** On August 27, 2026, [CDC declared the outbreak over](https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html) and, for the first time, stated causation affirmatively: epidemiologic, traceback and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick. [FDA’s closeout](https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026) the same day was more specific. One clinical sample from a Nara infant is a genetic match to a clinical sample from an infant in the 2025 ByHeart outbreak, to a ByHeart powdered infant formula base sample, and to four samples of unopened cans of ByHeart formula. FDA concluded that the matching sequencing results, together with the shared supply chain, indicate a common source of contamination between the two outbreaks. It has not determined whether the milk was contaminated before drying or during the drying process, and its root cause investigation remains open. Every counterpart in that match set is a ByHeart sample. That matters in two ways. The recovery of the outbreak organism from unopened ByHeart cans forecloses any suggestion that the strain which colonized the Nara infant was introduced in a home, at retail, or after a seal was broken; it was present in formula made from this milk before that formula left the manufacturer. And the second outbreak supplies a check on causation that cannot be attributed to anything peculiar to either company’s plant. Two infants, two brands, two manufacturers on different continents, seven months apart — and the only route between them is the dairy ingredient they shared. **The common source: Organic West Milk and Dairy Farmers of America** Liquid whole milk from twenty dairies is delivered to the Dairy Farmers of America plant in Fallon, Nevada, where it is spray dried into organic whole milk powder. Organic West Milk, acting as a broker, sells that powder to formula manufacturers. Nara’s own account of its supply chain puts it in the position ByHeart occupied: it bought Organic West whole milk from October 2024 to April 2025, that milk was dried at Dairy Farmers of America in Nevada, and the powder went into the formula Nara manufactured in Germany and sold in the United States from July 2025 forward. The ByHeart record establishes that powder from that chain carried viable *C. botulinum* — at least seventeen product samples tested positive in that investigation, five of them whole milk powder, including an FDA retain sampled at the Fallon plant. The record also shows how Nara was missed. On January 28 and February 3, 2026, FDA’s CORE network asked six firms that had received botulism-positive Organic West lots to identify every infant formula manufacturer they had supplied over the prior two years. None of the firms identified any. Separately, the customer list Organic West itself had given FDA during the ByHeart investigation omitted Nara. Nara formula had been on sale through Target and Nara.com since July 2025, squarely inside that window, and the first Nara-associated illness began about eight weeks after the last of those assignments closed. What FDA was not told, the public was. In late January 2026 the [Associated Press reported](https://abcnews.go.com/US/wireStory/companies-supplied-dried-milk-powder-linked-botulism-byheart-129650215) that Organic West Milk and the Dairy Farmers of America plant in Fallon were the source of the botulism-positive milk powder in the ByHeart outbreak, and quoted Dairy Farmers of America’s statement that the powder had met all required tests. **What Nara has said, and why it does not answer the evidence** Nara acknowledges that it learned from those media reports in early 2026 that Organic West and Dairy Farmers of America supplied ByHeart. It says it then conducted a rigorous review, confirmed that its whole milk powder lots did not overlap with ByHeart’s, reviewed its sulfite-reducing clostridia results, and determined that Nara formula could stay on the market. The four Nara infants became ill in April and May 2026, while formula made with that milk remained on sale. Nara’s [August 27, 2026 update](https://nara.com/pages/formula-recall-update-august-27-2026) describes FDA’s finding as one that may be linked to a former dairy supplier, and closes with the statement that FDA’s tests on sealed cans of Nara formula returned negative for botulinum toxin types A and B. That is the wrong test for this hazard. Infant botulism is caused by swallowed spores that germinate and produce toxin inside the baby’s intestine; the toxin is made in the infant, not in the can. A negative toxin assay on a sealed can says nothing about whether the can contained spores. The dairy switch confirms rather than limits the exposure. Nara stopped sourcing U.S. dairy in April 2025 and says its newer EU-dairy batches were not yet on sale when the recall came. By the company’s own description of a production lead time of nearly a year from purchase order to shelf, every can Nara sold in the United States was made with Organic West milk dried at Dairy Farmers of America. The switch to European dairy was a supply decision made before the ByHeart outbreak, not a response to it. And the testing Nara relies on is the testing that failed. Nara screens each batch for sulfite-reducing clostridia as a proxy for *C. botulinum*, and that program was in place when the outbreak lots were made and released. The 2026 FAO/WHO expert group concluded that hygiene indicators do not replace or reduce the need for pathogen-specific testing, and the peer-reviewed analysis of ByHeart product found *C. botulinum* in finished formula and base powder where that indicator organism was non-detectable. Dairy Farmers of America likewise said its powder met all required tests. Both companies in this chain point to their testing as proof of safety. The testing was the problem. **What FDA told the formula industry** On July 13, 2026, FDA wrote to the infant formula industry over the signature of Acting Deputy Commissioner for Food Donald A. Prater, DVM. The [letter](https://www.fda.gov/media/193534/download) states that a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier and every link in the supply chain; that suppliers of ingredients which will not receive a lethal treatment at the formula plant are an extension of the manufacturing process; and that recall notifications and outbreak investigations may serve as safety signals that an ingredient or supplier presents risk, with the warning that ignoring or downplaying such signals can lead to public health events that could have been avoided. Nara had exactly such a signal in January 2026. **Outbreak timeline** **Date** **Event** Oct 2024 – Apr 2025 Nara buys organic whole milk from Organic West Milk, spray dried by Dairy Farmers of America in Fallon, Nevada July 2025 Nara Organics formula goes on sale in the United States through Target and Nara.com Nov 2025 ByHeart infant formula botulism outbreak; ByHeart recalls all product Late Jan 2026 Associated Press names Organic West Milk and the Dairy Farmers of America Fallon plant as the source of botulism-positive milk powder Jan 28 & Feb 3, 2026 FDA CORE traceability assignments to six firms; none identifies an infant formula manufacturer customer Apr 20 – May 31, 2026 Four infants fall ill in California, Pennsylvania and Washington June 12, 2026 FDA and CDC notify Nara of three hospitalized infants June 13, 2026 Nara recalls all sixteen lots on the market July 6, 2026 CDC adds a fourth case; *C. botulinum* detected in an open can of Nara formula July 13, 2026 FDA letter to the infant formula industry Aug 27, 2026 CDC declares the outbreak over; FDA reports the sequencing match to ByHeart samples; root cause investigation remains open **If your infant was fed Nara Organics formula, preserve the evidence** Keep the can, the lid and the scoop, and photograph the lot code and your receipt or order confirmation. If your baby was treated, ask the hospital, the state public health laboratory or the [Infant Botulism Treatment and Prevention Program](https://www.infantbotulism.org/) to preserve the isolate and any stool specimen. Whole genome sequencing is what connects one infant’s illness to an outbreak strain, and isolates are routinely discarded once a case is closed. **You may have a claim** Families of infants hospitalized with botulism after being fed Nara Organics formula may have claims against Nara Organics, the retailer that sold the product, and the suppliers of the milk powder — Organic West Milk and Dairy Farmers of America. Marler Clark is examining product defect and failure to warn claims, the adequacy of Nara’s supplier verification and testing program under 21 C.F.R. Parts 106 and 117, and the decision to leave the formula on sale after the January 2026 reports identifying its milk supplier as the source of botulism-positive powder. Pennsylvania, Washington and California apply different limitation periods, and claims brought on behalf of a minor are governed by different rules than an adult’s. The time to file is limited in every state. **Botulism** Botulism is rare, but there is nothing else quite like it. The toxin produced by *Clostridium botulinum* is among the most potent poisons known, and it attacks the nervous system, causing a descending paralysis that can stop a person’s breathing. [Marler Clark, The Food Safety Law Firm](https://marlerclark.com/), is the nation’s leading firm representing victims of [botulism](https://about-botulism.com/) outbreaks. Our [botulism lawyers](https://marlerclark.com/food-litigation/botulism-outbreak-litigation) have represented thousands of victims in the only U.S. law practice devoted exclusively to foodborne illness, which has recovered more than $850 million for victims and families nationwide. We have handled botulism cases arising from carrot juice, pesto, cheese, chili, and improperly home-canned foods. Infant botulism works differently from the foodborne kind: rather than swallowing pre-formed toxin, a baby ingests spores that colonize the immature gut and produce the toxin there. Today we represent infants sickened in recent powdered infant formula botulism outbreaks, and we are working with Congress to pass legislation aimed at preventing the next one. If you or a family member developed botulism after eating contaminated food, contact the Marler Clark botulism attorneys for a [free case evaluation](https://marlerclark.com/contact). **Frequently asked questions** **What is botulism?** Botulism is a rare but life-threatening illness caused by a nerve toxin from the bacterium *Clostridium botulinum*, one of the most potent poisons known. It causes a descending paralysis that can stop breathing. Infant botulism differs from the foodborne form: a baby swallows spores that grow in the immature gut and produce the toxin there. **What foods cause botulism?** Improperly home-canned foods are the classic source, but outbreaks have also come from commercial products such as carrot juice, pesto, cheese sauce, and chili. Infant botulism has been linked to spores in honey and, more recently, in powdered infant formula. **What is infant botulism?** In infant botulism, a baby ingests *C. botulinum* spores that colonize the immature intestine and produce toxin internally. Early signs include constipation, a weak cry, poor feeding, and loss of muscle tone — the “floppy baby” presentation. **Is powdered infant formula being investigated?** Yes. We currently represent infants sickened in recent powdered infant formula botulism outbreaks, and we are working with Congress on legislation to require testing that could prevent the next one. **What should I do if my baby has these symptoms?** Seek emergency medical care immediately; infant botulism is treatable, and early treatment improves outcomes. Preserve any formula, containers, and lot numbers. **How many infants were sickened in the Nara Organics outbreak?** Four infants were confirmed with type A infant botulism after being fed Nara Organics Whole Milk Organic Infant Formula — two in California, one in Pennsylvania and one in Washington. All four were hospitalized and treated with BabyBIG. No deaths were reported. CDC declared the outbreak over on August 27, 2026. **Was the Nara Organics outbreak connected to the ByHeart outbreak?** Yes. FDA reported that whole genome sequencing matched a clinical sample from a Nara infant to a clinical sample from a ByHeart infant, to a ByHeart base powder sample, and to four samples of unopened cans of ByHeart formula. Both brands’ formula was made with organic whole milk supplied by Organic West Milk and spray dried by Dairy Farmers of America. FDA concluded the two outbreaks indicate a common source of contamination. **Additional resources** - • [About Botulism](https://about-botulism.com/) — a complete online resource on botulism and its causes - • [Botulism Blog](https://www.botulismblog.com/) — current news on botulism outbreaks and research - • [CDC outbreak page — infant botulism linked to powdered infant formula, June 2026](https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html) - • [FDA outbreak investigation — powdered infant formula, June 2026](https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026) - • [Infant Botulism Treatment and Prevention Program](https://www.infantbotulism.org/) **Other botulism lawsuits** - • [ByHeart Infant Formula tied to Botulism Outbreak](https://marlerclark.com/by-heart-infant-formula-tied-to-botulism-outbreak) - • [Botulism Outbreak at Valley Oak Food and Fuel](https://marlerclark.com/botulism-outbreak-at-valley-oak-food-and-fuel) - • [Marler Clark Files Two Botulism Lawsuits](https://marlerclark.com/marler-clark-files-two-botulism-lawsuits) **Get help** If your infant was hospitalized with botulism after being fed Nara Organics formula, contact Marler Clark for a free consultation. Call 1-800-884-9840, email , or use the form at [marlerclark.com/contact](https://marlerclark.com/contact). There is no charge to speak with us, and we handle these cases on a contingent fee — no attorney’s fee unless there is a recovery. ### Botulism news and updates October 16, 2022 ###### [Chai recalled due to Botulism risk](https://marlerclark.com/news_events/chai-recalled-due-to-botulism-rick) Marietta, GA, September 29, 2022 – The Chai Box announced a recall of 16 oz glass bottles Chai Concentrate Mix, UPC 7 93611 81925 … September 07, 2022 ###### [Bread recalled over Botulism risk](https://marlerclark.com/news_events/bread-recalled-over-botulism-risk) King’s Hawaiian is voluntarily recalling its Pretzel Slider Buns, Pretzel Hamburger Buns and Pretzel Bites products out of an abundance of caution following a recall … April 27, 2022 ###### [Washington man dies of botulism from home-canned food](https://marlerclark.com/news_events/washington-man-dies-of-botulism-from-home-canned-food) This past weekend, a Grays Harbor County man aged 55-65 passed away from a probable cause of botulism. No further information on the deceased is … [1. View all ](https://marlerclark.com/news_events/outbreaks) ## All Botulism Resources [###### What is Botulism? ](https://marlerclark.com/foodborne-illnesses/botulism/what-is-botulism) [###### Epidemiology and Microbiology of Botulism ](https://marlerclark.com/foodborne-illnesses/botulism/epidemiology-and-microbiology-of-botulism) [###### Symptoms of Botulism ](https://marlerclark.com/foodborne-illnesses/botulism/symptoms-of-botulism) [###### Detection and Treatment of Botulism ](https://marlerclark.com/foodborne-illnesses/botulism/detection-and-treatment-of-botulism) [###### Botulism Outcomes and Long-Term and Permanent Injury ](https://marlerclark.com/foodborne-illnesses/botulism/botulism-outcomes-and-long-term-and-permanent-injury) [###### Preventing Botulism ](https://marlerclark.com/foodborne-illnesses/botulism/preventing-botulism) [###### Botulism Outbreaks ](https://marlerclark.com/foodborne-illnesses/botulism/botulism-outbreaks) [###### Botulism References ](https://marlerclark.com/foodborne-illnesses/botulism/botulism-references) ### Other foodborne illnesses [E. coli](https://marlerclark.com/foodborne-illnesses/e-coli) [Salmonella](https://marlerclark.com/foodborne-illnesses/salmonella) [Listeria](https://marlerclark.com/foodborne-illnesses/listeria) [Hepatitis A](https://marlerclark.com/foodborne-illnesses/hepatitis-a) [Reactive Arthritis](https://marlerclark.com/foodborne-illnesses/reactive-arthritis) [Guillain-Barre Syndrome](https://marlerclark.com/foodborne-illnesses/guillain-barre-syndrome) [Irritable Bowel Syndrome](https://marlerclark.com/foodborne-illnesses/irritable-bowel-syndrome) [Norovirus](https://marlerclark.com/foodborne-illnesses/norovirus) [Botulism](https://marlerclark.com/foodborne-illnesses/botulism) [Campylobacter](https://marlerclark.com/foodborne-illnesses/campylobacter) [Shigella](https://marlerclark.com/foodborne-illnesses/shigella) [Cyclospora](https://marlerclark.com/foodborne-illnesses/cyclospora) [Hemolytic Uremic Syndrome](https://marlerclark.com/foodborne-illnesses/hemolytic-uremic-syndrome)