Food recall

ByHeart, INC. recall: 1

ByHeart, INC., of New York, NY, recalled 1. The FDA's reason: “Contaminated with Clostridium botulinum.” The FDA classified it Class I: it could cause serious harm or death. The company began the recall voluntarily on November 8, 2025, and the FDA first listed it in its Enforcement Report of December 17, 2025. The recall is still going on.

How serious

Class I

It could cause serious harm or death

Why

Other germs or toxins (botulism, hepatitis A, mold...)

Status

Ongoing

The recall

Company
ByHeart, INC. (New York, NY)
Reason, in FDA's words
“Contaminated with Clostridium botulinum”
Where it was sold
nationwide
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
97959

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • H-0249-2026 Class I

    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

    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

    Quantity: 3,482,131 Cans and 3,531,901 Single Serve Packets.

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of December 17, 2025.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.