FDA Recall United States OngoingHistorical recordClass I
ByHeart, INC.
- Product
- 1. ByHeart Whole Nutrition Infant Formula cans 24 OZ 680 gra…
- Published
- December 17, 2025
- Distribution
- Nationwide
ByHeart, INC. Recall: Infant formula potentially contaminated with Cronobacter sakazakii
United States
TerminatedClass I
- Company
- ByHeart, INC.
- Product
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680…
- Recall date
- December 11, 2022
- Terminated
- April 16, 2024
- Source
- FDA
Reason for recall
Infant formula potentially contaminated with Cronobacter sakazakii
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g | Not published in this source record | 28,554 cans | Packaged between September 30, 2022 and October 07, 2022 printed with following codes: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with best by 01 JAN 24 or 01 JUL 24 or 01SEP24 UPC Codes: 19589362296 |
Distribution
- nationwide direct to consumer subscription e-commerce sales
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0291-2023
- Event ID
- 91308
- Status
- Terminated
- Classification
- Class I
- Company
- ByHeart, INC.
- Product description
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
- Quantity
- 28,554 cans
- Reason
- Infant formula potentially contaminated with Cronobacter sakazakii
- Recall initiation date
- December 11, 2022
- Report date
- January 25, 2023
- Classification date
- Not published in this source record
- Termination date
- April 16, 2024
- Distribution pattern
- nationwide direct to consumer subscription e-commerce sales
- UPC, lot, and code information
- Packaged between September 30, 2022 and October 07, 2022 printed with following codes: 22273 C1, 22276 C1, 22277 C1, 22278 C1, and 22280 C1 with best by 01 JAN 24 or 01 JUL 24 or 01SEP24 UPC Codes: 19589362296
- 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.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
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 "Terminated." 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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