FDA recall H-0249-2026 · Dec 17, 2025
ByHeart, INC.: 1 recall
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
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your package, and look for the company's notice on FDA's recalls page. If you have the product and aren't sure, don't use it until you've checked.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- 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.
- Distribution
- nationwide
- Recalling firm
- ByHeart, INC., New York, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2025-11-08
Source: openFDA enforcement record H-0249-2026 · search recall number H-0249-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 14, 2026, 1:15 AM EDT. The agency notice is the final word.
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