New York, NY, United States
ByHeart, INC. recalls
2 recalls recorded since 2018, most recently on 8 November 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)2
Ongoing Class I Food
- Recall started
- 8 November 2025
- Reason
- Contaminated with Clostridium botulinum
- Distribution
- nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- H-0249-2026
- 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 containi
Terminated Class I Food
- Recall started
- 11 December 2022
- Terminated
- 16 April 2024
- Reason
- Infant formula potentially contaminated with Cronobacter sakazakii
- Distribution
- nationwide direct to consumer subscription e-commerce sales
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-0291-2023
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.