Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Food & Beverages
Foodborne Illness
Reason for Announcement:

Recall Reason Description

Potential Foodborne Illness – Clostridium botulinum

Company Name:
ByHeart Inc.
Brand Name:
Product Description:

Product Description

Whole Nutrition Infant formula 24 oz cans and 0.6oz packets

Company Announcement

This press release was updated on November 19, 2025; it replaces an earlier version issued on November 11, 2025.

[New York, NY] – ByHeart provides additional information regarding its voluntary recall that includes all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ and the related investigation. Clostridium botulinum is a bacterium which can cause life- threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The recall was initiated in response to an ongoing investigation into a recent outbreak of infant botulism and since then Clostridium botulinum was identified by ByHeart in some samples of its formula.

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and 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 possibly respiratory arrest. If your child is experiencing any of these symptoms, please seek medical attention immediately.

Product was distributed nationwide online and through retail stores. The recall includes all batch codes and use by dates for the following products:

  • ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800
  • ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Pack™, 14 packets per package, UPC: 5004496802

ByHeart is aware of the Food Safety Warning issued by the Canadian Food Inspection Agency (CFIA). ByHeart Whole Nutrition Infant Formula is only manufactured and distributed in the United States and is currently under voluntary recall. If Canadian residents have obtained ByHeart formula, they should stop using immediately.

What Consumers Should Do:

Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use and follow FDA guidance to:

  • Take a photo or record the information on the bottom of the package.
  • Keep the container in a safe spot and be sure to label that product as DO NOT USE.
  • If your child develops symptoms your state health department might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.

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:

If any parents have questions, please contact our experts at hello@byheart.com. For more information visit byheart.com or call 1 (833) 429 – 4327. We are available 24/7.

This action is being taken in close collaboration with the U.S. Food and Drug Administration (FDA).

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 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.”

ByHeart is taking proactive steps to do all it can to protect families. The company is actively:

  • Testing every batch of formula with an independent third-party laboratory. ByHeart partnered with IEH, a global leader in Food Safety testing, to test cans of ByHeart formula and learned that those tests identified Clostridium botulinum in some samples of ByHeart formula and immediately notified FDA of those findings.
  • Providing FDA and the California Department of Public Health (CDPH) full access to ByHeart facilities and cans to conduct testing without restriction
  • Sharing results from both regulatory and independent testing publicly as they become available

FDA and CDC, in collaboration with the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, continue to investigate a multistate outbreak of infant botulism.

As of November 19, 2025, a total of 31 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 15 states (see map). Laboratory confirmation for some cases is ongoing. For 27 cases with illness onset information available, illnesses started on dates ranging from August 9 to November 13, 2025. All 31 infants were hospitalized. No deaths have been reported to date. For 23 infants with age and 24 infants with sex information available, they range in age from 16 to 200 days, and 11 (46%) are female.

Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA

 

Media Contact:

ByHeart Public Relations - press@byheart.com

Link to Original Recall

FDA Outbreak Advisory