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CLASS I Β· SeriousFDABotulism

ByHeart, INC. recalls 1

πŸ“… Nov 8, 2025 Β· πŸ“ Nationwide
Recalling company
ByHeart, INC.
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
Contaminated with Clostridium botulinum
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Nov 8, 2025
Reported
Dec 17, 2025
Distribution
nationwide
Status
Ongoing
Quantity
3,482,131 Cans and 3,531,901 Single Serve Packets.
Lot / 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
Company location
New York, NY
Recall type
Voluntary: Firm initiated
Recall number
H-0249-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice β†— Search recall number H-0249-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

⚠️ If you have this product, don’t eat or use it. Return it to the store or throw it away, and follow the instructions in the official notice. If you feel sick, contact your healthcare provider. FoodRecallNow summarizes public data and is not affiliated with the FDA.

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