By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
ByHeart, INC. recalled this product and the FDA reported the enforcement action on 25 January 2023 as Class I. The recall was initiated by the firm. Infant formula potentially contaminated with Cronobacter sakazakii
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- By Heart Whole Nutrition Infant Formula, Net Wt. 24 oz. 680 g
- Reason for recall
- Infant formula potentially contaminated with Cronobacter sakazakii
- Recalling firm
- ByHeart, INC.
- Firm location
- New York, New York, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0291-2023
- Quantity
- 28,554 cans
- Distribution
- nationwide direct to consumer subscription e-commerce sales
- Initiated
- 11 December 2022
- Reported by FDA
- 25 January 2023
- Terminated
- 16 April 2024
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 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
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 16 months, from 11 December 2022 to termination on 16 April 2024. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of infant formula or baby food run a median of 10 months, so this one was longer than usual for its category. Infant formula is the most tightly regulated food in the United States because it is frequently the only thing an infant eats, so a nutrient deviation is a hazard in a way it is not in any other product.
Filed under infant formula and baby food. A product can sit in more than one.
Other infant formula and baby food recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from ByHeart, INC.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2025-12-17 | 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 | ByHeart, INC. | Contaminated with Clostridium botulinum | Class I |
All 2023 recalls · All FDA food recall data
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.