FDA refusal charge
FDA refusal charge NOT LISTED
Product not listed with FDA
NOT LISTED is the FDA import refusal charge for product not listed with FDA; it cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding). FDA recorded it on 371 refused shipment lines between October 2016 and October 9, 2026, most often for dietary supplements from India.
Data from FDA public records, last checked .
- 371
- refused shipment lines carry this charge
- 46
- countries of origin
- 0
- import alerts name this charge
What NOT LISTED means
The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.
This restates FDA's statement. It says what the charge means, never why a particular shipment was refused.
- FD&C Act section
- 502(o)801(a)(3)
- Classification
- misbranding
FDA's official statement
Copied unchanged from FDA's Refusal Charges reference table.
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Countries with the most NOT LISTED refusals
Shipment lines carrying NOT LISTED, by country of origin.
| Country | Lines | Share of NOT LISTED |
|---|---|---|
| India | 113 | 30% |
| China | 37 | 10% |
| Mexico | 26 | 7% |
| Guatemala | 18 | 5% |
| Canada | 13 | 4% |
| South Africa | 13 | 4% |
| Colombia | 12 | 3% |
| Brazil | 11 | 3% |
| Germany | 10 | 3% |
| El Salvador | 10 | 3% |
Product categories with the most NOT LISTED refusals
| Category | Lines | Share of NOT LISTED |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 346 | 93% |
| Dietary Conventional Foods and Meal Replacements | 12 | 3% |
| Food Sweeteners (Nutritive) | 7 | 2% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 3 | 1% |
| Coffee and Tea | 2 | 1% |
| Nuts and Edible Seeds | 1 | 0% |
Latest NOT LISTED refusals
The 20 most recent refused lines, through October 9, 2026, each with its FDA source.
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Sun Ten Pharmaceutical Co., LtdNew Taipei City, Taiwan | Noni (herbal & botanicals, not teas) | NOT LISTEDNO ENGLISH | Source | |
| Handa Health Care CenterCivil Lines, India | Herbals & botanicals (not teas), n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Agusto Formulation Pvt LtdGujarat, India | Coenzyme q10 (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | NOT LISTEDUNAPPROVED | Source | |
| Medopharm LtdMumbai, India | Ginkgo biloba (herbal & botanicals, not teas) | NOT LISTEDUNAPPROVED | Source | |
| Gsk LtdKarnataka, India | Vitamin b6 (pyridoxine) | NOT LISTEDUNAPPROVED | Source | |
| Biologische Heilmittel Heel GmbhBaden-Baden, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTED | Source | |
| Karma AyurvedaDelhi, India | Vitamin, n.e.c | NOT LISTEDFRNMFGREG | Source | |
| Shiva Biogenetics Lab Pvt LtdSolan, India | Psyllium (fiber) | NOT LISTEDUNAPPROVED | Source | |
| Cipla LtdSolan, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Indo Rama EnggPradesh, India | Vitamin d2 (calciferol) | NOT LISTEDUNAPPROVED | Source | |
| Hangzhou Lukang Biotech Co.,Ltd.Hangzhou, China | Herbals & botanicals (not teas), n.e.c | NOT LISTEDNO ENGLISHUNAPPROVED | Source | |
| Laboratorios Vijosa, S.A. de C.V.Antiguo Cuscatlan, El Salvador | Vitamin k (phytonadione) | NOT LISTEDFRNMFGREGUNAPPROVED+1 | Source | |
| Trumed PharmaceuticalsQuezon City, Philippines | Vitamin, n.e.c | NOT LISTEDNEW VET DR | Source | |
| Lukpue Drug IncQuezon City, Philippines | Vitamin b12 (cyanocobalamin) | NOT LISTEDNEW VET DR | Source | |
| Battlecock Livestock ProductsCabanatuan City, Philippines | Vitamin a | NOT LISTEDNEW VET DR | Source | |
| Linden-Apotheke M. Spiegel E.K.Graefenhainichen, Germany | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDNO ENGLISHFRNMFGREG+1 | Source | |
| MydawaNairobi, Kenya | Vitamin, n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Krm Ayurveda Pvt LtdNorth West Delhi, India | Vitamin c (ascorbic acid) | NOT LISTEDUNAPPROVED | Source | |
| Krm Ayurveda Pvt LtdNorth West Delhi, India | Ashwagandha (herbal & botanicals, not teas) | NOT LISTEDUNAPPROVED | Source | |
| Fluence Pharma Pvt. LtdMumbai, India | Vitamin, n.e.c | NOT LISTEDUNAPPROVED | Source |
Questions about NOT LISTED
- What does NOT LISTED mean on an FDA refusal?
- NOT LISTED is the refusal charge “Product not listed with FDA”. The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.
- What law does NOT LISTED cite?
- FDA's refusal charge table cites sections 502(o) and 801(a)(3) of the FD&C Act (misbranding) for NOT LISTED, 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 NOT LISTED refusals?
- As of October 26, 2026, the countries with the most NOT LISTED refusal lines are India (113), China (37) and Mexico (26). The full list with links is in the table on this page.
- Is there an FDA import alert for NOT LISTED?
- SupplierRadar found no food import alert whose charge section names NOT LISTED. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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