FDA recall H-0249-2026

ByHeart, INC. · Class I · food

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

Reason for recall

Contaminated with Clostridium botulinum

Distribution

nationwide

Key facts

Status: Ongoing
Initiation date: 2025-11-08
Report date: 2025-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=H-0249-2026