Recalls / Class I
Class IH-0249-2026
Class I— FDA's most serious classification, issued when there is a reasonable probability that consumption of or exposure to the product will cause serious adverse health consequences or death.
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
- Type
- Food
- Affected lot / code info
- 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.
Why it was recalled
Contaminated with Clostridium botulinum
Recalling firm
- Firm
- ByHeart, INC.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 131 Varick St, N/A, New York, New York 10013-1410
Distribution
- Distribution pattern
- nationwide
Timeline
- Recall initiated
- 2025-11-08
- FDA classified
- 2025-12-10
- Posted by FDA
- 2025-12-17
- Status
- Ongoing
Source: openFDA Food Enforcement endpoint. Recall record H-0249-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings.