Infant botulism cases put premium baby formulas under FDA scrutiny
Three new cases of infant botulism linked in June 2026 to Nara Organics formula, following dozens of cases tied to ByHeart in 2025, have put a class of premium infant formulas under FDA scrutiny, STAT News reports . No deaths have been reported, but affected infants were seriously ill — one 9-month-old in Houston spent 10 days intubated.
Both brands used organic whole milk powder rather than the standard nonfat powder, and the FDA matched Clostridium botulinum isolates from contaminated product to sickened infants. ByHeart’s whole milk powder came from a supplier processed at a Dairy Farmers of America facility. The agency says it is investigating the root cause across supply chains and production environments.
The cases expose a regulatory gap: companies are not required to test infant formula for C. botulinum, and the FDA offers no guidance to manufacturers on preventing it. The common thread of organic whole milk powder suggests an ingredient-level vulnerability that current rules were not written to catch, which is likely to drive pressure for mandatory testing.