FDA import refusals
FDA import refusals: dietary supplements from Ecuador
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 8, 2026
FDA refused 27 dietary supplements shipment lines from Ecuador between October 2016 and September 8, 2026, 13 of them in 2026; the most refused products were vitamin and herbals & botanicals, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 27
- dietary supplements lines refused since October 2016
- 13
- refused so far in 2026
- 1
- firms with the most records, listed below
Dietary supplements refusals from Ecuador by year
Shipment lines FDA refused each year. The table has the same numbers as the chart.
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 13 | |
| 2025 | 2 | -71% |
| 2024 | 7 | |
| 2020 | 5 |
Vitamin refusals from Ecuador
FDA refused 14 vitamin lines from Ecuador between October 2016 and September 8, 2026, 52% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 14 | 51.9% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Ecuador
FDA refused 8 herbals & botanicals lines from Ecuador between October 2016 and September 8, 2026, 30% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 8 | 29.6% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBLHEALTH C | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Nunalabs Cia LtdaQuito, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBL | Source | |
| Nunalabs Cia LtdaQuito, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBL | Source | |
| Laboratorio Genesis Labgenesis Cia. Ltda.Ambato, Ecuador | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source |
Herbals & botanical teas refusals from Ecuador
FDA refused 2 herbals & botanical teas lines from Ecuador between October 2016 and September 8, 2026, 7% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanical teas, n.e.c. | 2 | 7.4% |
Recent herbals & botanical teas refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Pablo Francisco Beltran SanchezQuito, Ecuador | Herbals & botanical teas, n.e.c | NO ENGLISHLABELINGNUTRIT LBL+1 | Source | |
| Pablo Francisco Beltran SanchezQuito, Ecuador | Herbals & botanical teas, n.e.c | LIST INGRENO ENGLISHLABELING+2 | Source |
Other dietary supplements products refused from Ecuador
| Product group | Lines | Share |
|---|---|---|
| Mineral n.e.c. | 1 | 3.7% |
| Plantain | 1 | 3.7% |
| Vitamin c | 1 | 3.7% |
Why FDA refused dietary supplements from Ecuador
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 20 | 38% |
| NO ENGLISH | Required label information not in English | 12 | 23% |
| LABELING | Fair Packaging and Labeling Act | 7 | 13% |
| NUTRIT LBL | Nutrition information missing from label | 7 | 13% |
| HEALTH C | Unauthorized nutrient content or health claim | 3 | 6% |
| NCONTACT | No U.S. adverse event contact on supplement label | 2 | 4% |
| LACKS FIRM | Manufacturer name and address missing | 1 | 2% |
| LIST INGRE | Ingredients not listed | 1 | 2% |
Import alerts for dietary supplements that list Ecuador firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-16 | Foods/supplements with active pharmaceutical ingredient | 1 |
Ecuador dietary supplements firms with the most FDA records
Counts are FDA records in SupplierRadar's data, not a ranking of quality.
| Firm | City | FDA records |
|---|---|---|
| Pablo Francisco Beltran Sanchez | Quito | 4 |
Latest dietary supplements refusals from Ecuador
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Carvagu S SGuayaquil, Ecuador | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBLHEALTH C | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Lambac S.A.Guayas, Ecuador | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Laboratorios LabmacDuran, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Munoz Pin Anderson RobertoGuayaquil, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Nunalabs Cia LtdaQuito, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBL | Source | |
| Nunalabs Cia LtdaQuito, Ecuador | Herbals & botanicals (not teas), n.e.c | LABELINGNUTRIT LBL | Source | |
| Laboratorio Genesis Labgenesis Cia. Ltda.Ambato, Ecuador | Mineral n.e.c | UNAPPROVED | Source | |
| Laboratorio Genesis Labgenesis Cia. Ltda.Ambato, Ecuador | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Pablo Francisco Beltran SanchezQuito, Ecuador | Herbals & botanicals (not teas), n.e.c | NO ENGLISHLABELINGNUTRIT LBL+1 | Source | |
| Pablo Francisco Beltran SanchezQuito, Ecuador | Herbals & botanical teas, n.e.c | NO ENGLISHLABELINGNUTRIT LBL+1 | Source | |
| Pablo Francisco Beltran SanchezQuito, Ecuador | Plantain (e.g., weed), (herbal & botanical teas) | NO ENGLISHLABELINGNUTRIT LBL+2 | Source | |
| Pablo Francisco Beltran SanchezQuito, Ecuador | Herbals & botanical teas, n.e.c | LIST INGRENO ENGLISHLABELING+2 | Source | |
| PhytopharmaY De Las Amapolas, Ecuador | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source |
Questions about dietary supplements refusals from Ecuador
- How many dietary supplements shipments from Ecuador did FDA refuse in 2026?
- FDA refused 13 shipment lines of dietary supplements from Ecuador in 2026 through September 8, 2026, compared with 2 in 2025.
- Why does FDA refuse dietary supplements from Ecuador?
- FDA records a charge code on every refused shipment line. For dietary supplements from Ecuador the most frequent are UNAPPROVED (unapproved new drug, 20 lines), NO ENGLISH (required label information not in English, 12 lines) and LABELING (Fair Packaging and Labeling Act, 7 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover dietary supplements from Ecuador?
- As of October 26, 2026, the FDA import alerts for this category that list Ecuador firms are Import Alert 54-16 (1 firm). General food alerts numbered 99-xx can list Ecuador firms too; see the country page.
Built for the person who signs the FSVP file
Buying dietary supplements from Ecuador?
Check each Ecuador supplier against every FDA record in one paste, free for five suppliers. Watch the ones you buy from and get the source the day a record changes.
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.