ByHeart Whole Nutrition Infant Formula

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Our Commitment to Your Family

ByHeart was built on the belief that babies deserve better: better science, better ingredients, better safety. The recent outbreak fell short of these values, and we are determined to prevent this from happening again. We have developed a comprehensive plan that reaffirms our commitment to safety and quality and outlines our corrective actions – from new testing methods to enhanced oversight.

Our C. bot Testing Commitment Read our Full Action Plan

Timeline of Key Events

SEPTEMBER 3 | REAGAN-UDALL FOUNDATION PUBLISHES INFANT FORMULA SAFETY REPORTAugust 28 | FDA Confirms Review of ByHeart's Root Cause Investigation and Action Plan, Following Completion of Facility InspectionsJune 26 | ByHeart’s Return-to-Market Plan Moves Forward with FDAJune 23 | ByHeart Introduces Advanced C. botulinum Safety ProtocolJune 10 | ByHeart Releases its Action PlanJune 3 | Facility Inspections ConcludeFEB 26 | OUTBREAK ENDSJan 21 - Feb 3 | ByHeart Submits Genetic Sequencing Data to Public Federal DatabaseJan 23 | Key FindingDec | Investigation deepensNov 19 | Positive ResultsNov. 7 – 11 | THE RECALL2016 | Why We Started

September 3, 2026

Reagan-Udall Foundation Publishes Report on the Science of Infant Formula Safety

On July 13, 2026, the Reagan-Udall Foundation for the FDA, in collaboration with ByHeart and the International Dairy Foods Association (IDFA), convened an invitation-only roundtable to examine insights from recent infant formula recall activity and the latest research on Clostridium botulinum. Participants represented the infant formula industry, academia, consumer advocacy, and the FDA.

The resulting report, Applying the Science of Infant Formula Safety: Insights From Recent Recall Activity and the Latest Research on C. botulinum, summarizes lessons learned from manufacturer and regulatory investigations and is organized around five key areas: the state of the science, data sharing, a collaborative multifactorial approach to safety, FDA collaboration, and potential next steps. It presents recommendations to advance research, establish standardize testing methods, strengthen data sharing, and improve collaboration across industry, academia, and government.

ByHeart shared its investigation findings, sample data, and evolved testing protocols to help establish a common scientific baseline for the discussion — work we're glad to have helped advance and remain committed to continuing.

Read More\ (opens in a new tab)

September 3, 2026

Reagan-Udall Foundation Publishes Report on the Science of Infant Formula Safety

August 28, 2026

FDA Confirms Review of ByHeart's Root Cause Investigation and Action Plan, Following Completion of Facility Inspections

ByHeart provided the U.S. Food and Drug Administration with an approximately 400-page comprehensive submission detailing the company's root cause investigation findings, assessments conducted by independent food safety experts, complete action plan, new Clostridium botulinum testing protocols, and proposed corrective actions and preventive controls across its supply chain and manufacturing operations. Additionally, FDA and ByHeart agreed on reviewing pending materials on ByHeart's proposed use of a new sporicidal treatment method for facility surfaces and a new whole milk ingredient supplier .

August 28, 2026

FDA Confirms Review of ByHeart's Root Cause Investigation and Action Plan, Following Completion of Facility Inspections

June 26, 2026

ByHeart’s Return-to-Market Plan Moves Forward with FDA

The FDA has reviewed our investigation findings, corrective actions, new testing protocols, and proposed preventative controls and confirmed it has no further questions. This follows the agency’s update on June 3 stating it had concluded ByHeart’s facility inspections and did not identify any deficiencies in our manufacturing facilities that could explain the root cause of this outbreak. There are remaining steps we are working through with the FDA before production resumes, and we will share updates as we complete them.

June 26, 2026

ByHeart’s Return-to-Market Plan Moves Forward with FDA

June 23, 2026

ByHeart Introduces Advanced C. botulinum Safety Protocol

New research conducted by ByHeart and IEH Laboratories, published in Frontiers in Microbiology, revealed that C. botulinum can be present at levels low enough to go undetected by the industry's standard screening method (SRC), but high enough to make babies sick. Working with IEH Laboratories, we developed the Advanced C. botulinum Safety Protocol – a purpose-built, dual-method test applied at three stages of production, and capable of detecting contamination 1,000x below the SRC detection limit by traditional direct plating methodology. We are sharing both the research and the protocol openly.

June 23, 2026

ByHeart Introduces Advanced C. botulinum Safety Protocol

June 10, 2026

ByHeart Releases its Action Plan

Since the start of the recall, we have cooperated closely with the FDA on a thorough root cause investigation into the Clostridium botulinum outbreak. Based on pivotal insights from the investigation, ByHeart's Action Plan outlines the steps we are taking to prevent this from happening again – covering new C. botulinum-specific testing protocols, enhanced supplier and ingredient quality assurance, manufacturing and facility improvements, and the establishment of an independent Food Safety Advisory Council. We are working toward the safe resumption of infant formula production, in close cooperation with the FDA.

June 10, 2026

ByHeart Releases its Action Plan

June. 3, 2026

FDA Concludes ByHeart Facility Inspections with No Deficiencies Tied to Botulism

FDA announced it has completed onsite inspections of ByHeart's facilities and it did not identify any deficiencies that could explain the root cause of this outbreak. The agency confirmed it is continuing to investigate the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified. FDA is working with ByHeart to safely resume infant formula production. As part of our Action Plan, a new C. botulinum-specific testing protocol will be applied to every dairy ingredient and finished batches before release.

Read More\ (opens in a new tab)

June. 3, 2026

FDA Concludes ByHeart Facility Inspections with No Deficiencies Tied to Botulism

Read More\ (opens in a new tab)

Feb. 26, 2026

CDC and FDA Declare Outbreak Over; Investigation Continues

CDC and FDA announced that the infant botulism outbreak had ended, with no new cases reported since December. FDA also confirmed that whole genome sequencing identified a match between two additional samples from a supplier lot of Organic Whole Milk Powder, a previously identified ByHeart formula sample, and a clinical sample from a child with infant botulism. FDA’s investigation into the root cause continues, and so does our work to learn from this outbreak.

Feb. 26, 2026

CDC and FDA Declare Outbreak Over; Investigation Continues

JAN. 21 – FEB. 3, 2026

ByHeart Submits Genetic Sequencing Data to Public Federal Database

As ongoing testing produced new results, ByHeart submitted raw C. botulinum genetic data from both finished product and ingredient samples to the NIH's National Center for Biotechnology Information (NCBI), a public federal database where food safety researchers and public health scientists can access what we found. This investigation generated a substantial body of data, and it is important to us that it is accessible to those working to advance the science around C. botulinum.

Read More\ (opens in a new tab)

JAN. 21 – FEB. 3, 2026

ByHeart Submits Genetic Sequencing Data to Public Federal Database

Read More\ (opens in a new tab)

Jan. 23, 2026

Root Cause Investigation Update

FDA shared a significant finding: genetic matches between two positive samples of C. botulinum Type A – one from ByHeart infant formula, and one from a sample of Organic Whole Milk Powder collected by FDA from our suppliers. This was a meaningful step forward. While the investigation was not yet complete, the evidence was continuing to point toward the ingredient supply chain.

Jan. 23, 2026

Root Cause Investigation Update

December 2025

Additional Cases; Investigation Deepens

FDA and CDC identified additional infant botulism cases linked to the outbreak.

IEH Laboratories, our independent food safety partner, also confirmed the presence of C. botulinum, the bacteria that causes infant botulism, in six of 36 finished product samples across two recalled batches. Whole genome sequencing, a highly precise genetic matching technique, conducted by IEH confirmed those results conclusively. The data was beginning to point us toward a source.

December 2025

Additional Cases; Investigation Deepens

FDA and CDC identified additional infant botulism cases linked to the outbreak.

Nov. 19, 2025

Positive Test Results in Unopened Cans

ByHeart’s testing confirmed the presence of C. botulinum in unopened cans of ByHeart formula. This was a critical and sobering finding. It told us the contamination had occurred before the product reached families. This helped inform the investigation and deepened our resolve to find the source.

Nov. 19, 2025

Positive Test Results in Unopened Cans

Nov. 7 – 11, 2025

Initial Notification and Full Recall

When the FDA notified us of a potential link between our formula and cases of infant botulism on November 7, we issued a voluntary recall of two batches within 24 hours and treated this with the urgency it demanded of us. Our team and resources were immediately directed to investigating what happened, working in full coordination with the FDA and regulators.

As the investigation developed quickly, we expanded that recall to include all ByHeart products and paused all production – notifying retailers and stakeholders in lockstep with regulatory guidance. Families who had trusted us, many of whom had chosen ByHeart because of our safety standards, were understandably upset. Getting answers was challenging, and some of our early communications made a frightening situation worse instead of better. This didn’t reflect our values of providing the care and clarity that families deserve and we resolved to make meaningful efforts in transparency as the investigation continued.

Nov. 7 – 11, 2025

Initial Notification and Full Recall

2016

ByHeart was founded because we believed babies deserved better. Better ingredients, better science, and a higher standard of care built from the ground up. We spent years getting that right before a single can ever reached a family. That mission is the same today as it was then. The November 2025 recall has made it even more urgent.

2016

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 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 email us at hello@byheart.com 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.

Visit Our Recall Hub for More Information

Our Guiding Experts

Our Third Party C. botulinum Advisors

We have brought together respected third-party laboratories and experts to collaborate on a comprehensive root cause investigation into the presence of Clostridium botulinum in ByHeart infant formula products. This investigation team includes IEH Laboratories, a premier regulatory consultancy of ex-FDA experts, and subject matter experts, Dr. Kathleen Glass and Dr. Eric Johnson.

Mansour Samadpour, MS, PhD

CEO, IEH Laboratories & Consulting Group

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Donald Zink, MS, PhD

President, IEH Laboratories & Consulting Group, Food & Regulatory Compliance

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Kathleen Glass, MS, PhD

Global subject matter expert in Clostridium botulinum

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Eric A. Johnson, MS, ScD

Subject matter expert and consultant on Clostridium botulinum

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Our Scientific Advisory Board

ByHeart collaborates with an independent Scientific Advisory Board made up of some of the world's leading infant nutrition PhDs and MDs who help guide the science behind our infant formula. This team of outside experts review our formula ingredients and nutrition, advise on research and testing, analyze data, and bring their knowledge of the latest scientific discoveries to help ensure our formula and practices are grounded in the most up-to-date science.

J. Bruce German, PhD

Distinguished Professor of Food Science and Technology, University of California, Davis

Bo Lönnerdal, PhD

Distinguished Professor Emeritus Nutrition and Internal Medicine, University of California, Davis

Catherine J. Field, PhD, RD, FCHAS

Professor of Agricultural, Life and Environmental Sciences, University of Alberta

Paolo Manzoni, MD, PhD

Professor and Chief of Pediatrics and Neonatology, Sant’Anna Hospital; Coordinator of the Italian Society of Neonatal Infectious Diseases

Steven Zeisel, MD, PhD

Professor of Nutrition and Pediatrics; Founding Director Nutrition Research Institute, University of North Carolina

Sharon M. Donovan, PhD, RD

Professor and Melissa M. Noel Endowed Chair in Nutrition and Health; Director of the Personalized Nutrition Initiative, University of Illinois

We’re here with support.

Please email us at hello@byheart.com

As parents ourselves, we understand how difficult this recall has been. For support, please email us and our Parent Experience team will assist you.

FAQs

When is ByHeart going to be available to buy again?

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.

Is the root cause investigation over?

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.

How will you test for Clostridium botulinum in your product going forward?

Developing and implementing new testing protocols is an important part of our Action Plan.

We worked with a reputable third-party lab partner, IEH Laboratories, to develop a new Clostridium botulinum-specific testing protocol with heightened sensitivity to previously used protocols. This will be applied to every dairy ingredient and to finished batches before they are released from our facilities. You can find more about this on our [testing page](/content/pages/testing "Testing"/index.html).

Is the whole milk powder the root cause of ByHeart’s Clostridium botulinum contamination?

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.

Does ByHeart have any connection to Nara Organics?

ByHeart and Nara Organics are separate companies with no corporate, financial, contractual, operational, or manufacturing relationship.

Do ByHeart and Nara Organics share any of the same suppliers?

ByHeart and Nara Organics are separate companies with no corporate, financial, contractual, operational, or manufacturing relationship.

On June 26, FDA and CDC published an update on Nara's recall noting that Nara Organics and ByHeart shared suppliers of organic whole milk and organic whole milk powder for a period of time. FDA has also stated that there is currently not enough evidence to determine if shared suppliers are the source or route of contamination in either outbreak. You can find the FDA’s update here(opens in a new tab).

Why did ByHeart suggest Nara Organics' formula as an alternative product for customers?

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.

Why did ByHeart remove the post about Nara Organics from Instagram?

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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