In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula

Summary

Company Announcement Date:

November 08, 2025

FDA Publish Date:

November 08, 2025

Product Type:

Food & Beverages

Reason for Announcement:

Recall Reason Description Potential Foodborne Illness – Clostridium botulinum

Company Name:

ByHeart Inc.

Brand Name:

Brand Name(s) ByHeart

Product Description:

Product Description Whole Nutrition Infant formula

Company Announcement

[New York, NY] – ByHeart , a next-generation baby nutrition company, announced today that, out of an abundance of caution, it has chosen to voluntarily recall two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism.

Infant botulism is a rare but potentially f