Severity
Critical
CriticalClass ITerminated
FDA Food recall · Reported November 22, 2023
DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
The recall
Paradise Flavors LLC issued this critical-severity FDA Food recall — Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40..
- Critical
- severity level
- 210 units
- affected scope
- Class I
- classification
- November 22, 2023
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0443-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0443-2024) was formally reported on November 22, 2023, with the manufacturer initiating the action on September 27, 2023. It is classified under Critical severity (Class I), with a current status of Terminated. Paradise Flavors LLC is listed as the recalling firm, operating out of Marathon, FL. Federal records list the affected scope as 210 units (pieces) from latest production.
The documented reason for this recall is: Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40. Distribution data in the federal record shows the product reached: Domestic distribution only, within state of Florida. No foreign distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Food — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Cosmetics & Personal Care recalls over time
Where this recall sits in its category — 1,052 cosmetics & personal care recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Affected scope
210 units (pieces) from latest production
Related Recalls
6
5 from same agency
Product description
DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
Reason for recall
Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | F-0443-2024 |
| Date reported | November 22, 2023 |
| Date initiated | September 27, 2023 |
| Recalling firm | Paradise Flavors LLC |
| Firm location | Marathon, FL |
| Affected scope | 210 units (pieces) from latest production |
| Distribution | Domestic distribution only, within state of Florida. No foreign distribution. |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0443-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.. Recalled by Paradise Flavors LLC. Units affected: 210 units (pieces) from latest production.
Why was this product recalled? ▼
Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on November 22, 2023. Severity: Critical. Recall number: F-0443-2024.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution only, within state of Florida. No foreign distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0443-2024) 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.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported November 22, 2023.
- 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.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.