Highest risk U.S. Food and Drug Administration

ByHeart Whole Nutrition Infant formula 24 oz cans and 0.6oz packets 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)ByHeart Infant formula & baby food — recalled infant formula & baby food (photo 3)ByHeart Infant formula & baby food — recalled infant formula & baby food (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Botulism risk

Botulinum toxin is what this recall guards against. It gives no warning in taste or smell, and a swollen or leaking container is a sign but not a reliable one.

What the notice says: Clostridium botulinum is a bacterium which can cause life- threatening illness or death.

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

Published
November 11, 2025
Risk level
Highest risk
Issued by
U.S. Food and Drug Administration
Brand
ByHeart
Product type
Infant formula & baby food
Distribution
Nationwide

Products covered by this recall

Whole Nutrition Infant formula 24 oz cans and 0.6oz packets

What the company announced

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:

Report a Product Problem through SmartHub

Complete an electronic Voluntary MedWatch form online

Complete a paper Voluntary MedWatch form that can be mailed to 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.

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 - [email protected]

Product Image:

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

Model or item number

On the rating label, the box or the instruction sheet.

  • 24 oz can

Package size

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

  • 24 oz
  • 0.6 oz
  • 0.60 oz

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 — Botulinum toxin is what this recall guards against. It gives no warning in taste or smell, and a swollen or leaking container is a sign but not a reliable one.

  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.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: ByHeart Inc. — Consumers: 1(833) 429-4327, [email protected] — Media: ByHeart Public Relations, [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 Clostridium botulinum is a bacterium which can cause life- threatening illness or death.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number 24 oz can. 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?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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