FDA import refusals
FDA import refusals: dietary supplements from Dominican Republic
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to June 28, 2026
FDA refused 40 dietary supplements shipment lines from Dominican Republic between October 2016 and June 28, 2026, 7 of them in 2026; the most refused products were herbals & botanicals and vitamin, most often for NUTRIT LBL (nutrition information missing from label).
Data from FDA public records, last checked .
- 40
- dietary supplements lines refused since October 2016
- 7
- refused so far in 2026
- 7
- firms with the most records, listed below
Dietary supplements refusals from Dominican Republic 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) | 7 | |
| 2025 | 1 | -67% |
| 2024 | 3 | |
| 2022 | 3 | -25% |
| 2021 | 4 | -43% |
| 2020 | 7 | +40% |
| 2019 | 5 | +25% |
| 2018 | 4 | -33% |
| 2017 | 6 |
Herbals & botanicals refusals from Dominican Republic
FDA refused 17 herbals & botanicals lines from Dominican Republic between October 2016 and June 28, 2026, 43% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 17 | 42.5% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | SUPPL GMPNCONTACTNUTRIT LBL | Source | |
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | SUPPL GMPNCONTACTNUTRIT LBL | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | NO ENGLISH | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source |
Vitamin refusals from Dominican Republic
FDA refused 15 vitamin lines from Dominican Republic between October 2016 and June 28, 2026, 38% 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. | 15 | 37.5% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Global Group V.M SRLSantiago, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDFRNMFGREGNO ENGLISH+1 | Source | |
| SagueSanto Domingo, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Tonic World Center S.A. de G.V.Centro, Leon, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNCONTACTNUTRIT LBL | Source | |
| Raquel UrenaSanto Domingo, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Gallo Lab, SRLSANTIAGO, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LABELING | Source |
Vitamin b12 refusals from Dominican Republic
FDA refused 4 vitamin b12 lines from Dominican Republic between October 2016 and June 28, 2026, 10% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin b12 (cyanocobalamin) | 4 | 10.0% |
Recent vitamin b12 refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source |
Other dietary supplements products refused from Dominican Republic
| Product group | Lines | Share |
|---|---|---|
| Vitamin a | 2 | 5.0% |
| Multiple vitamins | 1 | 2.5% |
| Vitamin e | 1 | 2.5% |
Why FDA refused dietary supplements from Dominican Republic
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NUTRIT LBL | Nutrition information missing from label | 11 | 15% |
| NO ENGLISH | Required label information not in English | 9 | 12% |
| NCONTACT | No U.S. adverse event contact on supplement label | 8 | 11% |
| UNAPPROVED | Unapproved new drug | 8 | 11% |
| LIST INGRE | Ingredients not listed | 7 | 9% |
| SUPPL GMP | Dietary supplement CGMP not met | 7 | 9% |
| UNSAFE COL | Color additive unsafe under section 721 | 7 | 9% |
| DIETARYLBL | Not identified as a dietary supplement | 6 | 8% |
| HEALTH C | Unauthorized nutrient content or health claim | 6 | 8% |
| NOT LISTED | Product not listed with FDA | 6 | 8% |
Import alerts for dietary supplements that list Dominican Republic firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-14 | Supplements from firms not meeting supplement GMP | 1 |
Dominican Republic 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 |
|---|---|---|
| Alopecil Corporation, S.R.L. | Santo Domingo | 15 |
| Nativo Trade S.R.L. | Manoguayabo | 5 |
| Rafael Gutierrez Beras | Santo Domingo | 4 |
| Lab Alfa SRL | STO DGO | 3 |
| Franklin Veras Sanchez | Santo Domingo | 3 |
| Laboratorios Alfa, SRL | Santo Domingo De Guzman | 2 |
| Unknown | UNKNOWN | 2 |
Latest dietary supplements refusals from Dominican Republic
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin a | NOT LISTEDHEALTH C | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Nativo Trade S.R.L.Manoguayabo, Dominican Republic | Vitamin b12 (cyanocobalamin) | NOT LISTEDFRNMFGREG | Source | |
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | SUPPL GMPNCONTACTNUTRIT LBL | Source | |
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | SUPPL GMPNCONTACTNUTRIT LBL | Source | |
| Global Group V.M SRLSantiago, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NOT LISTEDFRNMFGREGNO ENGLISH+1 | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | NO ENGLISH | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Lab Alfa SRLSTO DGO, Dominican Republic | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| SagueSanto Domingo, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHUNAPPROVED | Source | |
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | UNSAFE COLLIST INGREDIETARYLBL+6 | Source | |
| Tonic World Center S.A. de G.V.Centro, Leon, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNCONTACTNUTRIT LBL | Source | |
| Laboratorios Alfa, SRLSanto Domingo De Guzman, Dominican Republic | Vitamin e (tocopherol) | UNAPPROVED | Source | |
| Alopecil Corporation, S.R.L.Santo Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | LIST INGREUNSAFE COLSUPPL GMP+2 | Source | |
| Franklin Veras SanchezSanto Domingo, Dominican Republic | Herbals & botanicals (not teas), n.e.c | HEALTH C | Source | |
| Raquel UrenaSanto Domingo, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Gallo Lab, SRLSANTIAGO, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | LABELING | Source | |
| Laboratorios Alfa SRLSanto Domingo Oeste, Dominican Republic | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Dominican Republic
- How many dietary supplements shipments from Dominican Republic did FDA refuse in 2026?
- FDA refused 7 shipment lines of dietary supplements from Dominican Republic in 2026 through June 28, 2026, compared with 1 in 2025.
- Why does FDA refuse dietary supplements from Dominican Republic?
- FDA records a charge code on every refused shipment line. For dietary supplements from Dominican Republic the most frequent are NUTRIT LBL (nutrition information missing from label, 11 lines), NO ENGLISH (required label information not in English, 9 lines) and NCONTACT (no U.S. adverse event contact on supplement label, 8 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 Dominican Republic?
- As of October 25, 2026, the FDA import alerts for this category that list Dominican Republic firms are Import Alert 54-14 (1 firm). General food alerts numbered 99-xx can list Dominican Republic firms too; see the country page.
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