Class I U.S. Food and Drug Administration

1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams recall: Contaminated with Clostridium botulinum

Recall published 10 months ago

Contaminated with Clostridium botulinum

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: Contaminated with Clostridium botulinum

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
December 17, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ByHeart, INC.
Product type
Infant formula & baby food
Units affected
3,482,131 Cans and 3,531,901 Single Serve Packets.
Distribution
Nationwide
Made in
United States
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

1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2. ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams in packages containing 14 Single Serve Packets

Check your product

The notice names 14 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

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 — Food & cosmetics enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Botulism

ByHeart, INC. — 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. If anyone has eaten it and has blurred vision, trouble swallowing or weakness, call 911 — this does not wait for an appointment.
  3. 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.
  4. Throw it away so nobody else can retrieve it, or follow the disposal wording in the official notice if it specifies a method.

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.

Company contact: ByHeart, INC. — 131 Varick St, New York, NY, 10013-1410

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 — Food & cosmetics enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ByHeart, INC. infant formula & baby food recalled?

Contaminated with Clostridium botulinum Contaminated with Clostridium botulinum

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 850044968008, 850044968022, 00850044968893. 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?

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.

Where was the recalled product sold?

It was distributed nationwide.

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