FDA Recall United States Terminated Historical recordClass I
ByHeart, INC.
- Product
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680…
- Published
- January 25, 2023
- Distribution
- Nationwide
ByHeart, INC. Recall: Contaminated with Clostridium botulinum
United States
OngoingClass I
- Company
- ByHeart, INC.
- Product
- 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 gra…
- Recall date
- November 8, 2025
- Source
- FDA
Reason for recall
Contaminated with Clostridium botulinum
- - Recall initiated
- - Reported by source
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 3,482,131 Cans and 3,531,901 Single Serve Packets. | 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
- nationwide
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- H-0249-2026
- Event ID
- 97959
- Status
- Ongoing
- Classification
- Class I
- Company
- ByHeart, INC.
- 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
- Quantity
- 3,482,131 Cans and 3,531,901 Single Serve Packets.
- Reason
- Contaminated with Clostridium botulinum
- Recall initiation date
- November 8, 2025
- Report date
- December 17, 2025
- Classification date
- Not published in this source record
- Termination date
- Not terminated as of this source record
- Distribution pattern
- nationwide
- UPC, lot, and 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
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: ByHeart, INC.
Other recalls from ByHeart, INC.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
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