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August 27 Update

Published: August 27, 2026

 

CDC Declares Outbreak Over

The FDA and CDC announced on August 27 that the infant botulism outbreak is over, with a total case count of four. Our hearts are with these families, and all Nara families who experienced this recall. 

The FDA has indicated that Nara’s outbreak may be linked to one of our former dairy suppliers, the same ingredient suppliers as ByHeart’s 2025 outbreak. The FDA determined this based on Whole Genome Sequencing (WGS) analysis that showed a genetic link between a clinical sample in Nara’s outbreak and a clinical sample in ByHeart’s outbreak. More WGS results are below.

Nara stopped sourcing from U.S. dairy suppliers in April 2025 as we transitioned to a fully EU supply chain. Our most recent batches of infant formula, made with our EU dairy supplier, weren’t yet available for sale in June 2026 and were not part of the recall. Our plan is to bring Nara infant formula back to families with EU dairy and rigorous C. botulinum testing protocols in place. 

We’re grateful to know that the outbreak is over. As parents ourselves, we’re devastated that the families who fed Nara had to worry about their babies. Our mission is to serve Nara families again, with exceptional safety and nutrition guiding every decision we make. 


Whole Genome Sequencing 

The FDA performed Whole Genome Sequencing (WGS) analysis on 4 samples of C. botulinum related to this outbreak: 3 clinical samples collected from patients with infant botulism and 1 sample collected from an open can of Nara formula.

  • One clinical sample sequence clustered with a strain of C. botulinum found in a ByHeart clinical case from 2025, as well as base powder and unopened cans of ByHeart formula powder. The WGS from this clinical case does not match the strain from the open can of Nara formula collected from this patient’s home.
  • In the two other clinical cases, WGS does not match any strain of C. botulinum in the NCBI database, and the clinical strains also do not match each other.
  • The WGS of the open can of Nara formula does not match any strain of C. botulinum in the NCBI database and also does not match any of the 3 clinical samples.


Closed Can Testing
As part of the outbreak investigation, the FDA tested closed cans of Nara infant formula. All their tests on sealed cans of Nara infant formula have returned negative for C. botulinum toxin type A and toxin type B.