Recall Radar

ByHeart recalls 1. ByHeart Whole Nutrition Infant Formula cans: botulism risk

December 17, 2025 · ByHeart Class I

Class IFDA’s highest-risk class: a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Reason for the recallContaminated with Clostridium botulinum

Find the official FDA enforcement report

Recall at a glance

Recalling company
ByHeart
Location
New York, NY
Reported by FDA
December 17, 2025
Recall started
November 8, 2025
Risk class
Class I
Status (latest data we have)
Ongoing
Type
Voluntary: Firm initiated
Category
Supplements and infant formula
Reason type
BotulismOther contamination

Is my product affected?

Compare your product’s name, size and lot or date codes with the list below. A recall usually covers only specific codes.

  • 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
    Quantity: 3,482,131 Cans and 3,531,901 Single Serve Packets.
    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; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015

Where it was distributed

nationwide

What to do

If you have this product, check the codes above. FDA recall notices often tell consumers to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information, and if you are unsure, do not eat it. If someone becomes ill after eating a recalled food, contact a healthcare professional. See FDA’s recalls and safety alerts for company announcements.

Frequently asked questions

What was recalled?

ByHeart recalled 1 product, including 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….

Why was it recalled?

Contaminated with Clostridium botulinum

What does Class I mean?

FDA’s highest-risk class: a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Where was it sold or shipped?

nationwide

What should I do if I have this product?

Compare the product name, size and lot or date codes with the details on this page. FDA recall notices often tell you to stop eating the product and to return it or throw it away. Follow the company’s instructions and the official FDA information. If you are unsure, do not eat it.

More recalls from ByHeart

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Sources

Data provided by the U.S. Food and Drug Administration (FDA) through openFDA, shown as published and not validated by this site. This site is independent and is not affiliated with or endorsed by FDA. It covers FDA-regulated foods; meat, poultry and egg products are regulated by USDA. Do not rely on this site for medical decisions: for health concerns contact a healthcare professional, and always follow the official notice and the company’s instructions. Terms and disclaimer.