Home / Recalls / ByHeart, INC. / H-0249-2026

H-0249-2026 Class I Ongoing

Recalled by ByHeart, INC. — New York, NY

FDA food recall H-0249-2026 was initiated by ByHeart, INC. on November 8, 2025 and is designated Class I. Reason for recall: Contaminated with Clostridium botulinum The recall status is ongoing. Affected quantity: 3,482,131 Cans and 3,531,901 Single Serve Packets..

Recall Details

Product Type: Food
Report Date: December 17, 2025
Initiation Date: November 8, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,482,131 Cans and 3,531,901 Single Serve Packets.

Product Description

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 Pattern

nationwide

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