Food recall

ByHeart, INC. recall: By Heart Whole Nutrition Infant Formula

ByHeart, INC., of New York, NY, recalled By Heart Whole Nutrition Infant Formula. The FDA's reason: “Infant formula potentially contaminated with Cronobacter sakazakii.” The FDA classified it Class I: it could cause serious harm or death. The company began the recall voluntarily on December 11, 2022, and the FDA first listed it in its Enforcement Report of January 25, 2023. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class I

It could cause serious harm or death

Why

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

Status

Terminated

Closed April 16, 2024

The recall

Company
ByHeart, INC. (New York, NY)
Reason, in FDA's words
“Infant formula potentially contaminated with Cronobacter sakazakii”
Where it was sold
nationwide direct to consumer subscription e-commerce sales
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
91308

The product recalled

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

  • F-0291-2023 Class I

    By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g

    Codes: Packaged between September 30, 2022 and October 07, 2022 printed with following codes: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with best by 01 JAN 24 or 01 JUL 24 or 01SEP24 UPC Codes: 19589362296

    Quantity: 28,554 cans

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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 January 25, 2023.

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.