By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g

Infant formula potentially contaminated with Cronobacter sakazakii

Recall #: F-0291-2023
Affected scope: 28,554 cans
Initiated: December 11, 2022

Compiled from official public sources by the publisher. · Updated September 2026

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 recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

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

Structured summary of the FDA Food recall record
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.

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.

Nationwide recalls with similar severity or category timing

Food and dietary-supplement notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Critical), closest by report date among other firms and states.

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This recall: FDA Food, reported January 25, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026