Two infant botulism outbreaks. Seven months apart. Both involving organic whole-milk powdered infant formula. And now, new investigative reporting reveals that both brands used the same organic whole milk ingredient supplier.
This is not bad luck. It is a pattern, and it is pointing to a systemic gap in how the United States tests for one of the most dangerous pathogens in infant formula.
In November 2025, 48 infants across 17 states were sickened by infant botulism linked to ByHeart Whole Nutrition Infant Formula. Whole genome sequencing confirmed the link: the same strain of Clostridium botulinum was found in the organic whole milk powder, in the finished formula, and in the sick infants. In June 2026, three more infants in California, Pennsylvania, and Washington were hospitalized after consuming Nara Organics Whole Milk Organic Powdered Infant Formula. The investigation is ongoing, but the product type — organic whole-milk powdered formula — is identical.
Food Safety Magazine reported this week that Nara Organics and ByHeart shared a common supplier for organic whole milk powder: Organic West, dried by Dairy Farmers of America (DFA). Between October 2024 and April 2025, both brands sourced from the same supply chain.
Why This Matters
Until the ByHeart outbreak, Clostridium botulinum was not considered a hazard "reasonably likely to occur" in powdered infant formula manufacturing — which means it was not required to be specifically controlled for under the FDA's preventive controls regulations for infant formula.
Food Safety Magazine noted: "Until now, C. botulinum has not been considered to be a hazard reasonably likely to occur in powdered infant formula manufacturing." That regulatory classification matters, because it determines which hazards manufacturers are required to actively test for and control.
The standard test used in the industry — a sulfite-reducing clostridial (SRC) enumeration test — did not catch the contamination in either the ByHeart or the Nara Organics supply chain before infants were hurt.
What We Know So Far
The ByHeart Outbreak (November 2025): According to the FDA's investigation page, the ByHeart outbreak sickened 48 infants across 17 states, with illness onset dates ranging from late 2023 through late 2025. The outbreak was declared over on February 26, 2026, after no new cases were reported since December. FDA investigations confirmed C. botulinum Type A in the organic whole milk powder supplied through Organic West and processed at a DFA facility.
The Nara Organics Outbreak (June 2026): The Nara Organics recall, announced June 13, 2026, covers three confirmed hospitalizations in California, Pennsylvania, and Washington. No deaths. The formula was manufactured in Germany by Milchwerke Mittelelbe GmbH. The FDA's investigation into the root cause is ongoing.
The Shared Supplier: Food Safety Magazine reported that between October 2024 and April 2025, Nara Organics was using the same Organic West milk dried by DFA that ByHeart used. By the time the Nara outbreak was identified in June 2026, Nara had switched to an EU-based organic dairy supplier — but formula products containing DFA-processed milk were still in circulation when the ByHeart outbreak first surfaced.
A Warning That Went Unheeded
Food safety attorney Bill Marler, who has tracked both outbreaks, wrote in his Marler Blog: "The botulism outbreaks tied to ByHeart and now Nara Organics powdered infant formula were not freak events. They were not bad luck. They were predictable — predictable from the biology of the product, predictable from decades of published science, and predictable from a warning the FDA put in writing and mailed to this entire industry three years ago."
Marler notes that the FDA had previously identified the potential risk from C. botulinum spores in powdered infant formula in formal industry guidance distributed in 2023 — more than two years before the first outbreak. The regulatory requirement to specifically control for this hazard, however, did not follow.
After the ByHeart recall, the FDA had to send warning letters to Target, Walmart, Kroger, and Albertsons because recalled formula was still on shelves — in some cases restocked and discounted — weeks after the recall was issued.
The Testing Gap
The core problem, according to Food Safety Magazine, is that the standard industry testing protocol — SRC enumeration — "may not be sufficient to ensure powdered infant formula is free of C. botulinum." This is particularly concerning because C. botulinum spores can be distributed unevenly through a batch of powdered ingredient, meaning negative test results on sampled portions do not guarantee safety across all units.
ByHeart has committed to implementing a new C. botulinum-specific testing protocol for every dairy ingredient and finished batch before release, according to the company's website. The FDA confirmed it is working with ByHeart to safely resume production. But as of the Nara outbreak, no industry-wide regulatory update to testing requirements appears to have been issued.
What Experts Are Saying
Food Safety News quoted Seattle food safety attorney Bill Marler: "The pattern is more than troubling." He has called for the FDA to formally reclassify C. botulinum as a reasonably foreseeable hazard in powdered infant formula, which would require all manufacturers to actively control for it.
Food Safety Magazine's analysis notes that the ByHeart investigation provided the scientific confirmation that existing testing standards were inadequate — and that the Nara outbreak, occurring months later without resolution of that gap, demonstrates the consequence.
Who Faces the Greatest Risk?
Any infant currently consuming organic whole-milk powdered formula — particularly from smaller, specialty, or imported brands — faces an uncertain risk environment until regulatory standards are updated. The risk is concentrated in:
- Infants in the first six months of life, who are most susceptible to infant botulism
- Families who purchased Nara Organics or ByHeart formula during the affected distribution windows
- Infants fed formulas in the same supply chain as the implicated organic whole milk ingredient
Parents using any organic whole-milk powdered infant formula who have concerns should speak with their pediatrician.
What the Evidence Shows — and What It Does Not
Whole genome sequencing confirmed the ByHeart link beyond scientific doubt. The Nara investigation is ongoing, and no positive laboratory confirmation from formula samples has been announced. The supplier-overlap connection reported by Food Safety Magazine is a significant investigative finding, but is not yet an official FDA conclusion in the Nara case.
The FDA has not yet publicly updated its infant formula hazard analysis framework for C. botulinum, and no industry-wide regulatory change requiring C. botulinum-specific testing has been announced.
What You Can Do Now
- If you are using Nara Organics formula, stop immediately. All lots are recalled. Contact your pediatrician and monitor your infant for symptoms for 30 days after the last feeding.
- If you used ByHeart formula in 2024 or 2025 and your infant is older, that outbreak was declared over February 26, 2026.
- When choosing infant formula, speak with your pediatrician about the relative safety profiles of different product types and brands, particularly for specialty or imported formulas.
- The FDA's recall and outbreak investigation pages should be your primary source of updated information: FDA Outbreak Investigation — Nara Organics .
- If you want to submit comments on infant formula safety regulation, the FDA has an active public docket for infant formula safety standards.
Cost and Access: What Patients Should Know
Nara Organics formula may be returned to Target for a refund. Website orders from May and June 2026 have been automatically refunded. Parents with questions about formula alternatives should consult their pediatrician; no national formula shortage is expected from this recall.
What Happens Next
The FDA's investigation into the Nara Organics outbreak root cause is ongoing. Results of formula testing are expected in coming weeks. Regulatory review of whether C. botulinum should be formally classified as a reasonably foreseeable hazard in powdered infant formula manufacturing is expected to be part of the FDA's response to both outbreaks. MedicalDaily will report on any regulatory changes, investigation findings, or additional case counts.
The Bottom Line
Two organic baby formula botulism outbreaks in seven months — linked to the same ingredient supply chain — reveal a systemic gap in how the U.S. tests for one of the most dangerous pathogens in infant formula. The standard testing protocols did not catch this hazard before babies were hurt. The FDA's regulatory framework did not require them to. Parents using organic whole-milk powdered formula should be aware, stay current on all formula recalls, and consult their pediatrician with any concerns.
References
- Food Safety Magazine — Infant Formula Brands Behind Botulism Outbreaks Used Same Organic Whole Milk Supplier
- Food Safety Magazine — Organic Infant Formulas Caused Back-to-Back Botulism Outbreaks — What Gives?
- Food Safety News — New Infant Botulism Outbreak Linked to Imported Organic Powdered Formula
- FDA — Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)
- FDA — Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026)
- Marler Blog — Predictable: Two Formula Botulism Outbreaks the FDA Warned Us About Three Years Ago
- Consumer Reports — All Nara Organics Infant Formula Recalled Due to Botulism Concerns
