FDA recalls · H-0249-2026
ByHeart, INC. recall
- Food1. 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
- ReasonContaminated with Clostridium botulinum
- ClassClass I: most serious: the food could cause serious health problems or death
- StatusOngoing
- DatesFirm started it 2025-11-08. In FDA's enforcement report 2025-12-17.
- Sold innationwide
- Amount3,482,131 Cans and 3,531,901 Single Serve Packets.
- CodesAll 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
- FirmByHeart, INC., New York, NY · Voluntary: Firm initiated
Products we list
None. We tie a recall to a product only by a barcode printed in the recall, and this one names none we list. That does not mean the recalled food is missing from our listings.
From FDA's enforcement report, via openFDA (CC0): raw data for this recall. FDA's own Enforcement Report search finds it by its number, H-0249-2026. Class meanings: FDA.