Class IOngoing in FDA datasetNov 8, 2025

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…

Recalling firm: ByHeart, INC.

Why it was recalled

Contaminated with Clostridium botulinum

Check the codes ↓

The exact product

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

Check the codes

Compare these FDA-provided codes, lot numbers or dates with the product you have.

Match the product, size and code together. A similar name alone does not identify your batch.

Original FDA code information

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

Recall details

Recall number
H-0249-2026
Event ID
97959
FDA status
Ongoing
Initiated
Nov 8, 2025
Reported
Dec 17, 2025
Classified
Dec 10, 2025
Quantity
3,482,131 Cans and 3,531,901 Single Serve Packets.
Location
New York, NY, United States
Initiation type
Voluntary: Firm initiated
Notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Where it was distributed

nationwide

FDA source record · H-0249-2026

Data updated September 16, 2026. View official FDA data ↗

A missing code match is not a guarantee of safety. Follow official FDA and manufacturer guidance.