Class IOngoingVoluntary: Firm initiated
ByHeart, INC.: food recall H-0249-2026
ByHeart, INC. of New York, NY recalled 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 grams; Cans sold in 1 pack, 2 packs, 4 packs, or 6 packs 2.… Reason: Contaminated with Clostridium botulinum. The FDA listed it as Class I in its Enforcement Report dated Dec 17, 2025; distribution: nationwide.
Record status as published: Ongoing. openFDA data last updated Oct 21, 2026.
Have this product? Check FDA.gov and your retailer. This page reproduces an FDA Enforcement Report record and is not a public alert. Look for the firm's recall notice on the FDA's recalls page, or ask the store where you bought it what to do. If you think you got sick from a food, contact a health care provider.
Recall details
- 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
- Product quantity
- 3,482,131 Cans and 3,531,901 Single Serve Packets.
- Reason for recall
- Contaminated with Clostridium botulinum
- Codes, lots and dates on the package
- 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
- Recalling firm
- ByHeart, INC., New York, NY
- Classification
- Class I — the FDA uses this class for a situation in which there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
- Voluntary or mandated
- Voluntary: Firm initiated
- How the firm first notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Dates
| Event | Date |
|---|---|
| Recall initiated by the firm | Nov 8, 2025 |
| Classified by the FDA | Dec 10, 2025 |
| Published in the Enforcement Report | Dec 17, 2025 |
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Sources
- U.S. Food and Drug Administration, openFDA food enforcement reports, recall number H-0249-2026 (openFDA record). Data provided by the U.S. Food and Drug Administration (https://open.fda.gov).
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