Advancing Safety in Infant Formula
From the moment we identified Clostridium botulinum in our formula, we were committed to understanding how it happened and preventing it from ever happening again. What we found has fundamentally changed how we approach infant formula safety.
What We found
For years, ByHeart and the broader formula industry relied on a standard test called sulfite-reducing clostridia (SRC) to screen for a family of bacteria called Clostridia, as an early warning system for contamination.
The investigation following our 2025 recall revealed that the industry standard direct-plating SRC methodology lacks the sensitivity and specificity to detect C. botulinum at the lowest levels. The bacteria can be present at levels too low for this SRC method to catch, but high enough to make babies sick.
What We’re Doing About It
The research showed that ByHeart needed new testing protocols to be able to better identify and prevent C. botulinum contamination in infant formula. In partnership with IEH Laboratories, one of the world’s leading independent food testing and safety labs, we developed the Advanced C. botulinum Safety Protocol – a multi-layered testing approach built on two distinct methods, applied at three stages of production: ingredient-level, production-level, and post-production.
This protocol layers two unique testing methods at three stages of production. It is built on the foundation of the industry-leading global standard, “ISO Standardized Method,” together with a novel test method that was developed by IEH Laboratories specifically to aid this investigation. These are both PCR tests.
SRC remains an effective screen for many types of Clostridia, and we will continue to run it on our ingredients. By layering our new purpose-built, 2x3 C. botulinum testing protocol on top of SRC, we significantly increase the chances of detecting the specific presence of C. botulinum - down to 0.01 CFU/g.
ISO C. bot PCR Test
This internationally recognized PCR test looks for toxin genes or DNA sequences that produce the toxin. It indicates whether the
C. botulinum toxin genes are present.
IEH C. bot PCR Test
While the ISO test looks for the toxin, IEH’s PCR test looks for a caretaker gene that is present 100% of the time the toxin is. This gives us a different and accurate angle of detection.
IEH Laboratories & Consulting GroupThis dual testing approach can detect C. botulinum down to 0.01 CFU/g – that’s at least 1,000x more sensitive than the SRC detection limit by traditional direct plating methodology.
The work isn’t done.
This is one part of our broader Action Plan, which outlines every commitment we've made to prevent an outbreak like this from happening again.
We'll continue to share our progress on testing, our supply chain, on governance, and on every other promise we've made.
“As science evolves, so must we. New evidence shows that the industry standard sulfite-reducing clostridia (SRC) direct plating method is not a reliable enough indicator for Clostridium botulinum; we have a responsibility to acknowledge that openly and act on it.”
Dr. Devon Kuehn
Chief Medical Officer and Chief Scientific Officer, ByHeart
FAQs
ByHeart is working toward the safe resumption of infant formula production, in close cooperation with the FDA.
We don't have a specific timeframe to share yet. Returning to market is something we're working toward, but we won't resume production or sales until we're confident our safety protocols meet the standards we hold ourselves to.
The FDA has concluded its inspection of ByHeart's facilities and identified no deficiencies that could explain the root cause of the outbreak.
FDA is continuing its work focused on ingredients, including the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified. We do not have an anticipated timeline for the conclusion of that investigation, but we continue to offer our full cooperation.
As part of our Action Plan, we are prioritizing developing and implementing new testing protocols.
We worked with a reputable third-party lab partner to develop a new Clostridium botulinum-specific testing protocol with heightened sensitivity to previously used protocols that will be applied to every dairy ingredient and to finished batches before they are released from our facilities. We will share more on this soon.
FDA has concluded its facility inspections, and shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak.
FDA is continuing its investigation into ingredients, including the powdered milk ingredient produced by a third party supplier where Clostridium botulinum was identified.
FDA has shared their lab analysis and found genetic matches involving two positive samples of C. botulinum Type A: the first is a sample of ByHeart infant formula, and the second is a sample of whole milk powder collected by FDA from a supplier to ByHeart.
These findings are consistent with the whole genome sequencing (WGS) analysis conducted by ByHeart at IEH Laboratories, representing a concrete genetic match between the whole milk powder ingredient, finished ByHeart formula, and a clinical sample from a child with infant botulism from this outbreak.
We continue to offer our full cooperation as their investigation into ingredients continues.
ByHeart and Nara Organics are separate companies with no corporate, financial, contractual, operational, or manufacturing relationship.
ByHeart and Nara Organics are separate companies with no corporate, financial, contractual, operational, or manufacturing relationship. We do not have any insight into other organizations’ suppliers.
In November 2025, when ByHeart product was unavailable following our recall, we shared a Nara Organics discount code as a resource intended to help families identify alternative formula options quickly. That offer was discontinued after a short time. Parents currently using Nara Organics products should follow FDA, CDC, and Nara’s recall guidance and contact their pediatrician with any health concerns.
When ByHeart product was unavailable following our November 2025 recall, we shared a Nara discount code as one of the resources intended to help families identify alternative formula options quickly. That offer was discontinued after a short time but still lived on our feed. We removed the Instagram post for safety considerations following the Nara recall. While the offer is no longer valid, we did not want to take any chances. Parents currently using Nara Organics products should follow FDA, CDC, and Nara’s recall guidance and contact their pediatrician with any health concerns.
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