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

FDA recall notice · announced December 17, 2025 · Byheart

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: nationwide
Lot/code information: 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
Quantity: 3,482,131 Cans and 3,531,901 Single Serve Packets.
Status: Ongoing
Products in this recall event:
- 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 (H-0249-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.