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

By MANNA Foodbank

Summary

Company Announcement Date:

November 08, 2025

FDA Publish Date:

November 08, 2025

Product Type:

Food & Beverages

Reason for Announcement:

Potential Foodborne Illness – Clostridium botulinum

Company Name:

ByHeart Inc.

Brand Name:

ByHeart

Product Description:

Whole Nutrition Infant formula

Company Announcement

[New York, NY] – ByHeartExternal Link Disclaimer, 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 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.

  • The FDA has an ongoing investigation of infant botulism among babies in the U.S.
  • The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.
  • ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.

ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.

ByHeart adheres to the highest standards of Global and U.S. recommendations for product testing and safety. No ByHeart product has tested positive for any contaminants.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, Co-Founder and President. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”

Product Details for Voluntary Recall:

The voluntary recall applies to the following two batches of ByHeart infant formula:

  • Batch Code: 251261P2, Use by: 01 Dec 2026
  • Batch Code: 251131P2, Use by: 01 Dec 2026
  • UPC: 5004496800
  • Product Image : See below

The batch code and use by can be found on the bottom of the can.

No other ByHeart batches are impacted by this voluntary recall.

What Consumers Should Do:

Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product. If you’ve discarded any formula from the following batches, ByHeart will replace those cans at no cost.

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.comExternal Link Disclaimer or call 1 (833) 429 – 4327 We are available 24/7.

FDA Outbreak Advisory

Company Contact Information

Consumers:

(833) 429-4327

 hello@byheart.com.

Media:

 press@byheart.com

______________________________________________________________________________

* We believe that none of the product being recalled were processed or offered through the national office
* We strongly encourage you to notify your agencies within one business day from receipt of this notice.
* ALL cased and uncased inventories, both at the member level and agency level, need to be checked. This product may have entered member and agency warehouses through salvage, local donations, TEFAP, local purchases, retail pickups, food drives, or other avenues.
* For additional local details, please contact the Health Department(s) for the area(s) your food bank serves.
_____________________________________________________________________________
About Feeding America Recall Notices

The Feeding America national office issues notifications of all national Class I and II recalls–those involving a health hazard situation in which there is reasonable probability that eating the food will cause health problems or death–and other recalls that may affect the safety of food supplied to network members.

The national office strongly encourages all member product solicitors, operations managers, and others involved in food and grocery distribution to regularly consult resources provided by the United States Food and Drug Administration (FDA) at http://www.fda.gov/opacom/7alerts.html, and the United States Department of Agriculture (USDA) at http://www.fsis.usda.gov/Fsis_Recalls/index.asp. Additionally, members can often receive information on national, state, and local recalls by contacting their local health departments.

Feeding America National Office
Feeding America
161 N Clark, Suite 700
Chicago, IL 60601

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