ByHeart Safety & Education Hub
The latest updates and recall information
FDA and ByHeart Announce an Important Update on Root Cause Investigation
Date: January 23, 2026
On January 23, 2026, FDA shared that their lab analysis found genetic matches between Clostridium botulinum detected in a ByHeart formula sample and a sample of whole milk powder taken directly from a supplier to ByHeart. These findings are consistent with the analysis conducted by ByHeart and IEH Laboratories, with genetic matches between the whole milk powder ingredient, finished ByHeart formula, and a clinical sample shared by CDC from a child with infant botulism from this outbreak.
While FDA’s investigation remains underway, these new findings about the whole milk powder suggests we are significantly closer to determining the root cause of the contamination of ByHeart formula.
We are deeply sorry for the impact this outbreak has had on our community. We take our responsibility for our full supply chain very seriously and we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain. We will continue to share new progress updates with you.
Recall Status
All batches of ByHeart infant formula, and all products including cans and Anywhere Pack sticks nationwide, were recalled as of November 11, 2025.
We have paused all production of ByHeart products, as well as all marketing, advertising and influencer partnerships, and continue to direct our resources toward supporting families and the root cause investigation. Additional testing across ingredients, manufacturing processes, and handling procedures remains underway and we continue to cooperate fully with regulatory agencies.
ByHeart is providing a full refund for all products purchased on ByHeart.com on or after August 1, 2025. Please call us at 866-201-9069 and our team will assist you. For customers who purchased ByHeart products at retail stores, that retailer will handle your refund. We encourage customers to contact retailers directly to process their refunds.
Timeline of Key Events
FDA has shared their lab analysis and found genetic matches involving two positive samples of C. botulinum Type A collected by FDA: the first is a sample of ByHeart infant formula, and the second is a new sample of whole milk powder, collected by FDA from a supplier to ByHeart. While the FDA’s investigation is ongoing, these new findings about the whole milk powder that we source suggests that we are significantly closer to determining the root cause of the contamination of ByHeart formula.
ByHeart confirms positive test results for Clostridium botulinum in six of 36 samples of finished product tested. These six samples were taken from two batches (Batch 251261P2 and Batch 251131P2), and IEH confirmed these results as conclusive positives through whole genome sequencing. Both batches were in the initial product recall on November 8.
CDC includes 10 cases occurring from December 2023 through July 2025, identifying infants who were exposed to ByHeart formula before the August outbreak.
ByHeart reports that IEH tests identified Clostridium botulinum in some samples of ByHeart formula.
Upon learning from the FDA, CDC, and CDPH of additional cases of infant botulism connected to ByHeart formula, ByHeart expands recall to include all ByHeart products (all cans and Anywhere Pack sticks) nationwide. Parents are urged to stop using all ByHeart formula immediately.
Based on preliminary laboratory findings from California labs, CDC and FDA publicly confirm a multistate infant botulism outbreak linked to ByHeart formula.
ByHeart issues a voluntary recall of two batches of Whole Nutrition Infant Formula (251261P2 & 251131P2, use by Dec. 1, 2026).
ByHeart partners with IEH Laboratories to test cans and launches its investigation.
FDA notifies ByHeart of an ongoing botulism investigation linked to two batches of ByHeart infant formula.
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Investigation FAQs
While the FDA’s investigation is ongoing, the latest updates about the whole milk powder that we source suggests that we are significantly closer to determining the root cause of the contamination of ByHeart formula.
FDA has shared their lab analysis and found genetic matches involving two positive samples of C. botulinum Type A collected by FDA: the first is a sample of ByHeart infant formula, and the second is a new sample of whole milk powder, collected by FDA from a supplier to ByHeart.
These findings from FDA are consistent with the whole genome sequencing (WGS) analysis conducted by ByHeart at IEH Laboratories. These WGS sequences represent a second 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.
Our investigation has included a detailed examination of our facilities, processes and supply chain – from farm-level ingredients, to every piece of equipment at our owned facilities, through to the final finished product.
The investigation remains underway and we will provide new information as we learn more.
We remain committed to finding the facts and evidence about what led to the contamination of ByHeart products. We continue to work in cooperation with FDA to share new results from our ongoing investigation, which has included a detailed months-long examination of our facilities, processes and supply chain – from farm-level ingredients, to every step and piece of equipment of our owned manufacturing process, through to the final finished product.
ByHeart continues to test ingredients. We will provide updates on the conclusion of the investigation when we learn more.
At this time, testing for C. botulinum is not the industry standard. Instead, the industry (including regulators) relies on preventive controls, validated processing steps, and indicator tests, like SRC, to ensure stricter supplier selection and qualification.
We are working with our lab testing partner at IEH on new testing protocols for C. botulinum from farms, to supplier facilities, to our factories. Even though testing on the whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient. This outbreak revealed that this pathogen can make its way into the infant formula supply chain. Going forward, we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain.
To complement this enhanced testing, we are evaluating a comprehensive set of additional preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C. botulinum or other spore-forming bacteria. We will share further details as these are finalized.
All ByHeart suppliers must meet rigorous approval criteria designed to ensure the highest standards of safety, quality, compliance, and transparency.
The process begins with supplier pre-screenings, including evaluation of the company’s relevant certifications (such as SQF, BRCGS, or ISO), regulatory compliance, and alignment with ByHeart’s strict quality and food safety standards.
Qualified suppliers then undergo a comprehensive audit, including but not limited to a detailed review of pre-requisite programs, standard operating procedures, food safety and allergen control plans, environmental monitoring programs, heavy metal and contaminant testing policies, and detailed product specifications and certificates of analysis covering origin, analytical testing, and microbiological testing.
Suppliers are also assessed on sustainability and traceability practices, including ESG programs, and are classified through a detailed risk assessment.
ByHeart also conducts regular onsite or virtual audits to verify program execution, identify gaps requiring corrective actions and to ensure continued adherence to ByHeart’s stringent requirements.
ByHeart has extensive supplier specification in place covering milk products. This includes more stringent specifications that cover pathogens (B. cereus, Staphylococcus, E. coli and Salmonella), spores (total spore count & SRC), and hygiene indicators (Enterobacteriaceae and coliforms).
ByHeart also qualified for the Clean Label Project’s First 1,000 Day Promise Certification, meeting the most strict compliance requirements, inclusive of rigorous testing for pesticide, glyphosate, heavy metal, plasticizers, and prohibited ingredients.
We hold our ingredients to stringent limits for each specification.
ByHeart ensures ingredients are not contaminated after arrival through multi-layered controls designed specifically for infant safety.
Upon arrival at our production sites, shipments undergo strict security checks and anything of concern is immediately quarantined.
Ingredients remain on hold while documentation, such as Certificates of Analysis, lot codes, and specifications, are verified, packaging and labeling are inspected, and third-party laboratory testing is completed for identity, nutrients, and microbiological safety.
Once reviewed and approved by our Quality team, ingredients are stored under controlled environmental conditions, and they are further protected by validated sanitation programs, environmental monitoring, foreign material controls, and full lot-level traceability throughout manufacturing and packaging.
Yes. ByHeart maintains a robust Supplier Approval Program (SAP) aligned with FDA requirements and industry best practices.
The Supplier Approval Program is a process used to assess, approve, and continually monitor their ingredient, packaging, and service suppliers to ensure they meet safety, quality, and regulatory requirements.
This ensures all suppliers providing goods or services meet both regulatory standards and ByHeart’s standards for quality, safety, compliance, reliability, consistency and ethical practices before entering into or continuing a business relationship.
This framework is designed to mitigate risk, protect consumers, and support consistent operational excellence.
Based on the root cause investigation, our immediate focus is on creating and implementing enhanced testing and comprehensive preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C.botulinium or other spore-forming bacteria.
Even though testing on the organic grass-fed whole milk powder we received from suppliers exceeded industry and regulatory standards, we now know that the existing safeguards are insufficient. This outbreak revealed that this pathogen can make its way into the infant formula supply chain. Going forward, we are committing to instituting new testing protocols and conducting third-party testing for C. botulinum on every batch of our finished infant formula and throughout our supply chain.
To complement this enhanced testing, we are developing a comprehensive set of additional preventative controls throughout our supply chain and manufacturing process to further safeguard risk posed by C.botulinium or other spore-forming bacteria. We will share further details as these are finalized.
At this time, we are not naming specific suppliers we work with. We do not have visibility into who else they may be working with outside of ByHeart.
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