1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 p...

FDA Recall #H-0249-2026 — Class I — November 8, 2025

Recall #H-0249-2026 Date: November 8, 2025 Classification: Class I Status: Ongoing

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

Reason for Recall

Contaminated with Clostridium botulinum

Recalling Firm

ByHeart, INC. — New York, NY

Classification

Class I — A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.

Product Type

Food

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated