PlainRecalls
FDA Food Verify with FDA Food → Moderate Class II Terminated

Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*

Reported: November 15, 2023 Initiated: October 20, 2023 #F-0406-2024 283 kits units

Nutricia North America issued this FDA Food recall on November 15, 2023. Classified as Moderate severity (Class II). Approximately 283 kits units are affected. The recall was issued because: Incorrect product in packaging. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Food action (record #F-0406-2024) was formally reported on November 15, 2023, with the manufacturer initiating the action on October 20, 2023. It is classified under Moderate severity (Class II), with a current status of Terminated. Nutricia North America is listed as the recalling firm, operating out of Rockville, MD. Federal records indicate 283 kits units are affected.

The documented reason for this recall is: Incorrect product in packaging Distribution data in the federal record shows the product reached: 247 kits shipped within US (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carol…. 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, NHTSA and USDA FSIS 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 3 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.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

283 kits

Related Recalls

6

6 from same agency

Product Description

Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*

Reason for Recall

Incorrect product in packaging

Details

Recalling Firm
Nutricia North America
Units Affected
283 kits
Distribution
247 kits shipped within US (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin) 36 kits shipped within Canada (Ontario, Quebec, Prince Edward, British Columbia, Alberta)
Location
Rockville, MD

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-0406-2024
Date reported November 15, 2023
Date initiated October 20, 2023
Recalling firm Nutricia North America
Units affected 283 kits
Distribution 247 kits shipped within US (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia…

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

Scale of Impact

283 kits units affected — limited or regional distribution scale.

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

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?
Nutricia KetcoCal 4:1 LQ Unflavored in 237ml (8fl oz) packaged in tetra prisma paper aseptic carton - 3 cartons per box *Sample Kits*. Recalled by Nutricia North America. Units affected: 283 kits.
Why was this product recalled?
Incorrect product in packaging
Which agency issued this recall?
This recall was issued by the FDA Food on November 15, 2023. Severity: Moderate. Recall number: F-0406-2024.
Where was the recalled product distributed?
Distribution: 247 kits shipped within US (Alabama, California, Colorado, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin) 36 kits shipped within Canada (Ontario, Quebec, Prince Edward, British Columbia, Alberta).
How do I check if my product is affected by a recall?
Check the product description and recall number (F-0406-2024) 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 moderate severity, indicating the product may cause temporary or medically reversible health consequences. 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

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • 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)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product 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.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).