RecallRadar
FDA · FoodClass I

ByHeart, INC. food recall: 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams

Botulism riskMicrobial contamination

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Food
Classification
Class I
Status
Ongoing
Event ID
97959
Recall initiated
Nov 8, 2025
Classified by FDA
Dec 10, 2025
Posted in Enforcement Report
Dec 17, 2025
Recalling firm
ByHeart, INC.
Firm location
New York, NY, United States
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Products in this event
1

What to do

Compare the product name, size, UPC, lot codes and dates below with the product you have. If it matches, do not eat it. Follow the firm's instructions to return it or throw it away.

View the official FDA record ↗

Reason for recall

Contaminated with Clostridium botulinum

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Nov 8, 2025. FDA classified it 32 days later, on Dec 10, 2025. Distribution reported by FDA: nationwide ByHeart, INC. has 2 recalls in our records.

Recalled products (1)

  • H-0249-2026 Class I Ongoing

    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 / lots: 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.

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA food enforcement dataset
Official notice
FDA Enforcement Report, event 97959
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.