ByHeart Broadens Voluntary Recall While Investigation Continues

Summary

Company Announcement

[New York, NY] – ByHeart a next-generation baby nutrition company, announced today that it is expanding its voluntary recall to include all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide. This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA), despite the fact that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin. This action underscores ByHeart’s core mission: protecting babies above all else.

“The safety and well-being of every infant who uses our formula is, and always will be, our highest priority,” said Mia Funt, Co-Founder and President of ByHeart. “This nationwide recall reflects our commitment to protecting babies and giving families clear, actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve.

While the FDA is awaiting confirmed results of its testing, ByHeart is taking proactive steps to do all it can to protect families. The company is actively:

• Recalling all product from the market while the FDA’s comprehensive investigation seeks to identify a root cause of the broader outbreak
• Testing every batch of formula with an independent third-party laboratory—a process which has already begun
• Providing FDA and the California Department of Public Health (CDPH) full access to our facilities and unopened cans to conduct testing without restriction
• Sharing results from both regulatory and independent testing publicly as they become available

Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possible respiratory arrest. If your child is experiencing any of these symptoms, please seek medical attention immediately.

The FDA and CDC have been conducting a broader investigation into a spike of 84 infant botulism cases that started in August. Once ByHeart was alerted on November 7, 2025, the company acted decisively. The results of the FDA’s investigation into the broader cases will help inform any additional steps as our own investigation continues.

What Consumers Should Do:

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

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. 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 the FDA.

If any parents have questions please contact our experts at [email protected]. For more information visit byheart.com or call 1 (833) 429-4327 We are available 24/7.

Media Contact:

ByHeart Public Relations – [email protected]

Product Details for Voluntary Recall:

The voluntary recall now applies to all batches of ByHeart Whole Nutrition Infant Formula cans and all Anywhere Packs:

• Can UPC: 85004496800
• Anywhere Pack (™) UPC: 85004496802
• Product Image:

Link to Original Recall

FDA Outbreak Advisory