Two separate multistate outbreaks of infant botulism — one linked to ByHeart powdered formula in 2025 and another to Nara Organics in 2026 — have now been tied together by whole-genome sequencing and a shared supply chain. A draft petition filed with the FDA this week asks the agency to require testing of finished infant formula and dairy ingredients for Clostridium botulinum spores. Comments are due by October 30.
Background
Infant botulism occurs when Clostridium botulinum spores germinate in a baby’s immature gut and produce toxin. It is rare, but when it happens it can cause progressive flaccid paralysis, including of the muscles needed for breathing. Until 2025, no botulism outbreak had ever been linked to powdered infant formula. Then ByHeart’s Whole Nutrition formula was associated with 48 hospitalizations (28 confirmed, 20 probable) across 17 states, with illness onsets stretching back to late 2023. All infants were treated with BabyBIG; none died. CDC declared that outbreak over in February 2026.
In April–May 2026 a second cluster appeared: four confirmed cases (California, Pennsylvania, Washington) among infants who had consumed Nara Organics Whole Milk Organic Powdered Infant Formula. Nara recalled all lots in June. CDC declared that outbreak over on August 27, 2026. Whole-genome sequencing later showed that a clinical isolate from one Nara infant matched a clinical isolate from a ByHeart infant, a ByHeart base-powder sample, and four unopened cans of ByHeart formula. Both products used milk supplied by Organic West Milk and spray-dried by Dairy Farmers of America. FDA has stated that the matching sequences and shared supply chain indicate a common source of contamination, though the precise point (before or during drying) remains under investigation.
What changed this week
Food-safety attorney Bill Marler, representing parents of 23 hospitalized infants (21 from ByHeart, 2 from Nara), submitted a draft petition requesting that C. botulinum testing be added to the list of required analyses for infant formula and relevant dairy ingredients. The petition notes that environmental sampling at ByHeart plants was negative while the organism was recovered from a lot of organic whole-milk powder that matched a sick infant. Sampling of powdered-milk suppliers has also turned up Clostridium strains carrying botulinum toxin genes. The petition argues that a rule focused only on the manufacturing environment would have missed the contamination.
Competing viewpoints
Manufacturers and some industry groups have emphasized the technical difficulty of detecting low levels of heat-resistant spores in large volumes of powder, the lack of a validated rapid method suitable for routine finished-product testing, and the fact that spores are widespread in the environment. They point to existing supplier-qualification programs and the absence of deaths in either outbreak as evidence that current controls, combined with rapid clinical recognition and BabyBIG, are sufficient. Public-health advocates and the petitioning parents counter that two outbreaks linked to the same ingredient suppliers in less than a year demonstrate a gap that voluntary letters and post-outbreak investigations have not closed. They note that FDA’s own root-cause work is still ongoing and that adding a specific pathogen to the testing list would create a clear, enforceable expectation for both formula makers and ingredient suppliers.
What to watch next
- The October 30 comment deadline on the draft petition.
- Whether FDA issues any new guidance or proposes a rule on spore-forming organisms in infant formula.
- Results of the agency’s ongoing root-cause investigation into the shared milk-powder supply.
- Any further recalls or testing findings involving powdered dairy ingredients used in infant formula.
For parents currently using powdered formula, the practical steps remain the same: follow the manufacturer’s preparation instructions exactly (including boiling water if directed), store cans properly, and seek immediate medical care if an infant develops constipation, weak cry, poor feeding, or progressive weakness. The two outbreaks are over, but the petition and the shared-supply-chain finding keep the issue on the regulatory agenda.
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