Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8…
Mead Johnson & Company LLC recalled this product and the FDA reported the enforcement action on 24 January 2024 as Class I. The recall was initiated by the firm. Product has the potential to be 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
- Enfamil Nutramigen Hypoallergenic Infant Formula Powder with Iron cans (12.6 OZ and 19.8 OZ). UPC Code of 300871239418 or 300871239456 and Use By Date of "1 Jan 2025".
- Reason for recall
- Product has the potential to be contaminated with Cronobacter sakazakii.
- Recalling firm
- Mead Johnson & Company LLC
- Firm location
- Zeeland, Michigan, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0809-2024
- Quantity
- 1,396,438 cans
- Distribution
- Retail stores and medical facilities nationwide and outside the U.S.
- Initiated
- 30 December 2023
- Reported by FDA
- 24 January 2024
- Terminated
- 13 August 2025
- Firm notified by
- Press Release
- Product codes
- ZL3FHG (12.6 oz cans) ZL3FMH (12.6 oz cans) ZL3FPE (12.6 oz cans) ZL3FQD (12.6 oz cans) ZL3FRW (19.8 oz cans) ZL3FXJ (12.6 oz cans)
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 19 months, from 30 December 2023 to termination on 13 August 2025. 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 4 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.
All 2024 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.