← FDA ENFORCEMENT
H-0249-2026Class I

ByHeart, INC.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
ByHeart, INC.
Product type
Food / supplement / cosmetic
Status
Ongoing
Report date
2025-12-17
Distribution
nationwide
Firm state
NY
Product quantity
3,482,131 Cans and 3,531,901 Single Serve Packets.
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Contaminated with Clostridium botulinum

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →