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

Summary

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 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:

• 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.

FDA Outbreak Advisory