PlainRecalls
FDA Food Verify with FDA Food → Critical Class I Terminated

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".

Reported: January 24, 2024 Initiated: December 30, 2023 #F-0809-2024 1,396,438 cans units

The recall

Mead Johnson & Company LLC issued this critical-severity FDA Food recall — Product has the potential to be contaminated with Cronobacter sakazakii..

Critical
severity level
1,396,438 cans
units affected
Class I
classification
January 24, 2024
reported

Sourced from official FDA Food enforcement records. Verify recall #F-0809-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Food action (record #F-0809-2024) was formally reported on January 24, 2024, with the manufacturer initiating the action on December 30, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Mead Johnson & Company LLC is listed as the recalling firm, operating out of Zeeland, MI. Federal records indicate 1,396,438 cans units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Product has the potential to be contaminated with Cronobacter sakazakii. Distribution data in the federal record shows the product reached: Retail stores and medical facilities nationwide and outside the U.S.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Food. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Where this recall sits in the database

Severity2119858883High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified high severity.

Severity

Critical

Units Affected

1,396,438 cans

Related Recalls

6

6 from same agency

Product Description

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.

Details

Units Affected
1,396,438 cans
Distribution
Retail stores and medical facilities nationwide and outside the U.S.
Location
Zeeland, MI

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-0809-2024
Date reported January 24, 2024
Date initiated December 30, 2023
Recalling firm Mead Johnson & Company LLC
Units affected 1,396,438 cans
Distribution Retail stores and medical facilities nationwide and outside the U.S.

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1,396,438 cans units affected — million-unit bracket.

Regional (<10K units)
Multi-state (10K – 100K units)
Large-scale (100K – 1M units)
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled?
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".. Recalled by Mead Johnson & Company LLC. Units affected: 1,396,438 cans.
Why was this product recalled?
Product has the potential to be contaminated with Cronobacter sakazakii.
Which agency issued this recall?
This recall was issued by the FDA Food on January 24, 2024. Severity: Critical. Recall number: F-0809-2024.
Where was the recalled product distributed?
Distribution: Retail stores and medical facilities nationwide and outside the U.S..
How do I check if my product is affected by a recall?
Check the product description and recall number (F-0809-2024) 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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as critical severity, meaning the product carries a reasonable probability of serious adverse health consequences or death. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported January 24, 2024.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).