FDA refusal charge
FDA refusal charge RX LEGEND
RX LEGEND is the FDA import refusal charge for the article appears to be a prescription drug without a prescription drug legend as required by Section…; it cites sections 502(a) & (f)(1) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 5 refused shipment lines from 2 countries between October 2016 and August 31, 2026, most often for seafood from France.
Data from FDA public records, last checked .
- 5
- refused shipment lines carry this charge
- 2
- countries of origin
- 0
- import alerts name this charge
What RX LEGEND means
SupplierRadar has not written a plain-English version of RX LEGEND yet. FDA's own statement is quoted below.
- FD&C Act section
- 502(a) & (f)(1)801(a)(3)
- Classification
- misbranding
FDA's official statement
The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
Countries with the most RX LEGEND refusals
| Country | Lines | Share of RX LEGEND |
|---|---|---|
| France | 4 | 80% |
| El Salvador | 1 | 20% |
Product categories with the most RX LEGEND refusals
| Category | Lines | Share of RX LEGEND |
|---|---|---|
| Fishery/Seafood Products | 4 | 80% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 1 | 20% |
Latest RX LEGEND refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorios Vijosa, S.A. de C.V.Antiguo Cuscatlan, El Salvador | Vitamin k (phytonadione) | NOT LISTEDFRNMFGREGUNAPPROVED+1 | Source | |
| Capitaine NatPia, France | Sardines (brisling, sprats, pilchards, etc.) | LABELINGRX LEGENDNO PROCESS | Source | |
| Capitaine NatPia, France | Sardines (brisling, sprats, pilchards, etc.) | LABELINGRX LEGENDNO PROCESS | Source | |
| Capitaine NatPia, France | Sardines (brisling, sprats, pilchards, etc.) | LABELINGRX LEGENDNO PROCESS | Source | |
| Capitaine NatPia, France | Sardines (brisling, sprats, pilchards, etc.) | LABELINGRX LEGENDNO PROCESS | Source |
Questions about RX LEGEND
- What does RX LEGEND mean on an FDA refusal?
- RX LEGEND is the refusal charge “The article appears to be a prescription drug without a prescription drug legend as required by Section…”. FDA's official statement for the charge reads: “The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).”
- What law does RX LEGEND cite?
- FDA's refusal charge table cites sections 502(a) & (f)(1) and 801(a)(3) of the FD&C Act (misbranding) for RX LEGEND, and classifies the charge as misbranding. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most RX LEGEND refusals?
- As of October 26, 2026, the countries with the most RX LEGEND refusal lines are France (4) and El Salvador (1). The full list with links is in the table on this page.
- Is there an FDA import alert for RX LEGEND?
- SupplierRadar found no food import alert whose charge section names RX LEGEND. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.