1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams
Recalled by ByHeart, INC.
Food recall
ByHeart, INC.
Class I — most serious
There is a reasonable chance that using this product could cause serious health problems or death.
ByHeart, INC. has recalled 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 17, 2025 and was initiated on November 8, 2025. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams, with approximately 3,482,131 Cans and 3,531,901 Single Serve Packets. affected. The company behind the recall is ByHeart, INC., based in New York, NY. The FDA describes the product as: “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”
According to the official notice, the recalled product was sold at Sam's Club & Amazon. If you shop there, check your purchases against the details below.
Why was 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams recalled?
According to the FDA, the stated reason for the recall is: “Contaminated with Clostridium botulinum.” In plain terms, this recall relates to Clostridium botulinum.
Clostridium botulinum is a bacterium that can produce a toxin causing botulism, a rare but serious illness most often associated with improperly processed canned or packaged foods. Because of the potential severity, regulators act quickly on any related contamination.
What should you do?
If you think you may have bought 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams, compare it against the product description and identifying codes (All batches and codes within expiry Finished Product Quantity 08NOV2023 to 08NOV2025 UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Ama…) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact ByHeart, INC. or your local health authority.
About this recall
This recall was distributed in NY. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Who this recall affects
This recall matters most to infants, especially newborns and premature babies. Cronobacter infections are rare but can be very serious for babies, which is why formula recalls move quickly.
The official notice names Sam's Club & Amazon among the places this product was sold, so if you shop there it's worth a look in your kitchen, pantry, or garage.
What Clostridium botulinum actually means
Clostridium botulinum is a bacterium that can produce a toxin causing botulism, a rare but serious illness most often associated with improperly processed canned or packaged foods. Because of the potential severity, regulators act quickly on any related contamination.
In this case, the concern applies specifically to 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams from ByHeart, INC. — not to the wider category of products. Similar items from other brands aren't part of this recall.
How to check whether you have it
On packaged food, lot codes and best-by dates are usually printed in small date-coding ink on the side seam, the bottom of the package, or near the top seal — not on the front label. The UPC barcode is on the back or bottom.
Compare what you find against the identifying details in this recall: 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
What to do if you already bought it
Do not eat the product, even if it looks and smells normal — contamination is usually invisible.
Return it to the store for a refund, or throw it away in a sealed bag so pets and wildlife can't reach it.
If it touched other food or surfaces, wash those surfaces and your hands with hot soapy water. When in doubt, contact ByHeart, INC. or your local health department.
Full recall details
- Status
- Ongoing
- Date reported
- December 17, 2025
- Recall started
- November 8, 2025
- Distributed in
- NY
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams recalled?+
According to the FDA: Contaminated with Clostridium botulinum
How serious is this recall?+
Class I — most serious. There is a reasonable chance that using this product could cause serious health problems or death.
What should I do if I have 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: H-0249-2026. Information last synced from the FDA on September 7, 2026.