Class I U.S. Food and Drug Administration

ByHeart Whole Nutrition Infant formula recall: Potential Foodborne Illness – Clostridium botulinum

Recall published 12 months ago

Potential Foodborne Illness – Clostridium botulinum

ByHeart Infant formula & baby food — recalled infant formula & baby foodByHeart Infant formula & baby food — recalled infant formula & baby food (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Botulism risk

This notice is about a possible botulism risk, which is the one food recall where "I will deal with it later" is the wrong answer.

What the notice says: 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.

Why it matters: This product may not have been processed in a way that reliably destroys Clostridium botulinum spores. The toxin they can produce in a sealed container is one of the most dangerous substances in food safety, and it is tasteless and odourless.

Symptoms and when to call a doctor

Botulism is a medical emergency. The CDC lists double or blurred vision, drooping eyelids, slurred speech, difficulty swallowing, a dry mouth, and muscle weakness that starts in the face and moves down the body. In an infant, watch for poor feeding, a weak cry, drooping eyelids and unusual floppiness. Call 911 or go to an emergency department immediately if any of these appear after eating a recalled product — treatment works best when it is given early.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
H-0249-2026
Published
November 8, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ByHeart
Product type
Infant formula & baby food
Units affected
3,482,131 Cans and 3,531,901 Single Serve Packets.
Distribution
Nationwide
Lot / code info
All batches and codes within expiry Finished Product Quantity 08NOV2023 to 08NOV2025 UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015
UPC codes
850044968008, 850044968022, 00850044968893, 00850044968053, 850044968015

Products covered by this recall

Whole Nutrition Infant formula

What the company announced

[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.

Expanded Recall

FDA Outbreak Advisory

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 850044968008
  • 850044968022
  • 00850044968893
  • 00850044968053
  • 850044968015

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 251261P2
  • 251131P2

Package size

Match the net weight or the piece count on the front of the pack.

  • 24 OZ
  • 680 grams
  • 1 pack
  • 2 packs
  • 4 packs
  • 6 packs
  • 17 grams
  • 2 PK
  • 1 Count

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Botulism

ByHeart — This notice is about a possible botulism risk, which is the one food recall where "I will deal with it later" is the wrong answer.

  1. Do not taste it. Not even a small amount, and not to check whether it has turned.
  2. Wash anything the contents spilled on with a bleach solution and wear gloves while you do it.
  3. If anyone has eaten it and has blurred vision, trouble swallowing or weakness, call 911 — this does not wait for an appointment.
  4. Do not open the container. If it is already open, do not sniff it — double-bag it and keep it away from children and pets.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Remedy named in the notice: Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product.

Company contact: ByHeart Inc. — Consumers: (833) 429-4327, [email protected]. — Media: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ByHeart infant formula & baby food recalled?

Potential Foodborne Illness – Clostridium botulinum 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 850044968008, 850044968022, 00850044968893; lot code 251261P2, 251131P2. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Do not taste it. Not even a small amount, and not to check whether it has turned.

Can I get my money back?

The notice says: Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product.

Where was the recalled product sold?

It was distributed nationwide.

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