Important Recall Information

ByHeart is providing a full refund for all products purchased on ByHeart.com on or after August 1, 2025.

Where Things Stand:

June 10,2026

Recall Remains in Place: All batches of ByHeart Whole Nutrition Infant Formula remain recalled as of November 11, 2025. If you have product at home, please discontinue use immediately. Production of all ByHeart products remains paused at this time.
ByHeart Facility Inspections: We have cooperated fully with FDA on their inspections of our Portland, OR and Allerton, IA facilities – the two facilities that were operational at the time of the recall. After a thorough investigation, FDA has shared that it did not identify any deficiencies in ByHeart’s facilities that could explain the root cause of this outbreak. You can follow FDA's full findings to-date here.
Root Cause Analysis: Over the past several months, ByHeart and IEH Laboratories have been working on an exhaustive root cause assessment as part of FDA’s ongoing investigation into the outbreak. The most significant finding to date is a positive genetic match of C. botulinum between a whole milk powder ingredient supplied to ByHeart, finished ByHeart formula, and clinical cases of infant botulism. FDA has shared it is continuing its investigation into ingredients, including the powdered milk ingredient produced by a third-party supplier where Clostridium botulinum was identified.

We have developed a comprehensive Action Plan outlining the concrete steps we are taking — from new testing protocols and supplier standards to facility safeguards and independent oversight.

Read our Action Plan

How to receive your refund:

All customers are eligible for a full refund for all ByHeart.com purchases placed on or after August 1, 2025. Please email us at hello@byheart.com and our team will assist you.
We are carefully managing a high volume of customer payments at this time. Once you connect with our team, you should expect to receive funds within 5-7 days. Thank you for your patience.
For customers who purchased ByHeart products at Retail stores, that retailer will handle your refund. We encourage you to contact them directly to process your refund for ByHeart infant formula.

For support, please email

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.

Next Steps for Parents & Caregivers

Immediately discontinue use of all ByHeart products

• Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use of the product.

• Label and safely store open products following CDC guidance
Monitor for Signs & Symptoms

According to the American Academy of Pediatrics, the sign of Infant Botulism appears at an estimated 3 to 30 days from the time of consumption of the Clostridium botulinum bacteria.

Signs & symptoms infant botulism include:
• Constipation
• Poor feeding
• Difficulty sucking or swallowing
• Weak or altered cry
• Overall weakness Low muscle tone
• Drooping eyelids
• Breathing difficulty or respiratory distress

To report an illness or adverse event, you can:
• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem;
• Complete an electronic Voluntary MedWatch form online;
• Complete a paper Voluntary MedWatch form that can be mailed to FDA.

How infant botulism is treated:

The CDC recommends treatment with BabyBig (Botulism Immune Globulin Intravenous (Human)) based on clinical symptoms. Please reach out to your healthcare provider immediately if you suspect your baby is experiencing symptoms of infant botulism.
In an Emergency, Seek Medical Attention

Call 911 or go to the nearest emergency room if you feel your baby is experiencing a medical emergency.