Why it was recalled
Contaminated with Clostridium botulinum
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
nationwide
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- H-0249-2026
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 8, 2025
- FDA report date
- Dec 17, 2025
- Quantity
- 3,482,131 Cans and 3,531,901 Single Serve Packets.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ByHeart, INC.
Original FDA data
Every field from FDA enforcement report H-0249-2026, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 97959
- Address
- 131 Varick St
- 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
- Postal code
- 10013-1410
- Report date
- Dec 17, 2025
- Product type
- Food
- Recall number
- H-0249-2026
- Classification
- Class I
- Recalling firm
- ByHeart, INC.
- Product quantity
- 3,482,131 Cans and 3,531,901 Single Serve Packets.
- Reason for recall
- Contaminated with Clostridium botulinum
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- nationwide
- Recall initiation date
- Nov 8, 2025
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Dec 10, 2025