# FDA recall F-0291-2023

> **ByHeart, INC.** · Class I · food recall initiated 2022-12-11.

## Product

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

## Reason for recall

Infant formula potentially contaminated with Cronobacter sakazakii

## Distribution

nationwide direct to consumer subscription e-commerce sales

## Key facts

- **Recall number:** F-0291-2023
- **Recalling firm:** ByHeart, INC.
- **Classification:** Class I
- **Product type:** food
- **Status:** Terminated
- **Initiation date:** 2022-12-11
- **Report date:** 2023-01-25
- **Termination date:** 2024-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New York, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-0291-2023

## Citation

> AI Analytics. FDA recall F-0291-2023. Retrieved 2026-06-29 from https://api.ai-analytics.org/recall/F-0291-2023. Source: US FDA. Licensed CC0.

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