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Recall Observatory FDA recall evidence

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

H-0249-2026

November 08, 2025

Class I

Product summary

Firm
ByHeart, INC.
Event
Event 97959
Status
Ongoing
Classification
Class I
Quantity
3,482,131 Cans and 3,531,901 Single Serve Packets.
Official record key
food-enforcement:H-0249-2026

Official wording

Reason: Contaminated with Clostridium botulinum

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

Distribution pattern: nationwide

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Contaminated with Clostridium botulinum