Severity
Critical
CriticalClass ITerminated
FDA Food recall · Reported January 25, 2023
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
Infant formula potentially contaminated with Cronobacter sakazakii
Compiled from official public sources by the editorial team.
Verify with FDA Food →
ByHeart, INC. recalled By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g - a critical-severity action.
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g was recalled by ByHeart, INC. in January 25, 2023. Reason: Infant formula potentially contaminated with Cronobacter sakazakii. Check the official notice for the remedy. Verify recall #F-0291-2023 with the FDA Food before acting.
The recall
ByHeart, INC. issued this critical-severity FDA Food recall-Infant formula potentially contaminated with Cronobacter sakazakii.
- Critical
- severity level
- Class I
- classification
- January 25, 2023
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0291-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0291-2023) was formally reported on January 25, 2023, with the manufacturer initiating the action on December 11, 2022. It is classified under Critical severity (Class I), with a current status of Terminated. ByHeart, INC. is listed as the recalling firm, operating out of New York, NY. Federal records list the affected scope as 28,554 cans.
The documented reason for this recall is: Infant formula potentially contaminated with Cronobacter sakazakii Distribution data in the federal record shows the product reached: nationwide direct to consumer subscription e-commerce sales. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
28,554 cans
Related Recalls
6
0 from same agency
Product description
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
Reason for recall
Infant formula potentially contaminated with Cronobacter sakazakii
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | F-0291-2023 |
| Date reported | January 25, 2023 |
| Date initiated | December 11, 2022 |
| Recalling firm | ByHeart, INC. |
| Firm location | New York, NY |
| Affected scope | 28,554 cans |
| Distribution | nationwide direct to consumer subscription e-commerce sales |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0291-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g. Recalled by ByHeart, INC.. Units affected: 28,554 cans.
Why was this product recalled? ▼
Infant formula potentially contaminated with Cronobacter sakazakii
Which agency issued this recall? ▼
This recall was issued by the FDA Food on January 25, 2023. Severity: Critical. Recall number: F-0291-2023.
Where was the recalled product distributed? ▼
Distribution: nationwide direct to consumer subscription e-commerce sales.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0291-2023) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported January 25, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.