FDA import refusals
FDA import refusals: dietary supplements from Mexico
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 8, 2026
FDA refused 1,132 dietary supplements shipment lines from Mexico between October 2016 and October 8, 2026, 131 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 .
- 1,132
- dietary supplements lines refused since October 2016
- 131
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Mexico 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) | 131 | |
| 2025 | 127 | -13% |
| 2024 | 146 | +51% |
| 2023 | 97 | -66% |
| 2022 | 285 | +400% |
| 2021 | 57 | -36% |
| 2020 | 89 | -15% |
| 2019 | 105 | +200% |
| 2018 | 35 | -26% |
| 2017 | 47 | |
| 2016 (from Oct) | 13 |
Vitamin refusals from Mexico
FDA refused 681 vitamin lines from Mexico between October 2016 and October 8, 2026, 60% 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. | 632 | 55.8% |
| Vitamin, n.e.c. | 49 | 4.3% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Omega NutritionHidalgo Del Parral, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | ADDDRUGBIO | Source | |
| Merck, S.A. de C.V.Naucalpan De Juarez, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| RmUnknown, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source |
Herbals & botanicals refusals from Mexico
FDA refused 87 herbals & botanicals lines from Mexico between October 2016 and October 8, 2026, 8% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 87 | 7.7% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Herbalfoods, S.A. de C.V.Guadalajara, Mexico | Herbals & botanicals (not teas), n.e.c | NEEDS FCENO PROCESS | Source |
Vitamin c refusals from Mexico
FDA refused 42 vitamin c lines from Mexico between October 2016 and October 8, 2026, 4% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin c (ascorbic acid) | 42 | 3.7% |
Recent vitamin c refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Bayer de Mexico, S.A. de C.V.Lerma, Mexico | Vitamin c (ascorbic acid) | UNAPPROVED | Source |
Other dietary supplements products refused from Mexico
| Product group | Lines | Share |
|---|---|---|
| Vitamin b12 | 36 | 3.2% |
| Vitamin b1 | 30 | 2.7% |
| Glucosamine hydrochloride | 22 | 1.9% |
| Multiple vitamins | 21 | 1.9% |
| Folic acid | 15 | 1.3% |
| Herbals & botanical teas | 11 | 1.0% |
Why FDA refused dietary supplements from Mexico
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 697 | 39% |
| NO ENGLISH | Required label information not in English | 421 | 23% |
| NUTRIT LBL | Nutrition information missing from label | 278 | 15% |
| LABELING | Fair Packaging and Labeling Act | 124 | 7% |
| NCONTACT | No U.S. adverse event contact on supplement label | 103 | 6% |
| INCONSPICU | Required information not conspicuous | 38 | 2% |
| DIETARYLBL | Not identified as a dietary supplement | 36 | 2% |
| HEALTH C | Unauthorized nutrient content or health claim | 35 | 2% |
| LACKS N/C | Net quantity statement missing | 35 | 2% |
| FALSE | False or misleading labeling | 33 | 2% |
Import alerts for dietary supplements that list Mexico firms
Mexico 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 |
|---|---|---|
| Plantas Medicinales de Mexico | DELEGACION XOCHIMILCO C.P | 171 |
| Omega Nutrition | Hidalgo Del Parral | 127 |
| Tonic Life S de RL | Irapuato | 34 |
| Natural Provida | Guadalajara | 24 |
| Merck, S.A. de C.V. | Naucalpan De Juarez | 22 |
| Laboratorio y Red de Distribucion Vital Health S.A. de C.V. | Hermosillo | 16 |
| True Herbs | Michoacan | 16 |
| Herbolaris Internacional | Zapopan | 15 |
| Corporativo Serysi, S. De R.L. De C.V. | Zapopan | 14 |
| Laboratorios Tornel, S.A. | Naucalpan | 13 |
Latest dietary supplements refusals from Mexico
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| MercNaucalpan De Juarez, Mexico | Vitamin b6 (pyridoxine) | UNAPPROVED | Source | |
| Bayer de Mexico, S.A. de C.V.Lerma, Mexico | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Herbalfoods, S.A. de C.V.Guadalajara, Mexico | Herbals & botanicals (not teas), n.e.c | NEEDS FCENO PROCESS | Source | |
| Laboratorio y Red de Distribucion Vital Health S.A. de C.V.Hermosillo, Mexico | Vitamin a | FALSE | Source | |
| Omega NutritionHidalgo Del Parral, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | ADDDRUGBIO | Source | |
| Merck, S.A. de C.V.Naucalpan De Juarez, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| RmUnknown, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| RmUnknown, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | DIETARYLBLNO ENGLISHNUTRIT LBL | Source | |
| Laboratorio Kimik BotanikZapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Laboratorios ShelaCoyoacan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Best S ABenito Juarez, Mexico | Multiple vitamins (mvi-12 vitamin combo) (vitamin) | UNAPPROVED | Source | |
| Merck, S.A. de C.V.Naucalpan De Juarez, Mexico | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, Mexico | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source |
Questions about dietary supplements refusals from Mexico
- How many dietary supplements shipments from Mexico did FDA refuse in 2026?
- FDA refused 131 shipment lines of dietary supplements from Mexico in 2026 through October 8, 2026, compared with 127 in 2025.
- Why does FDA refuse dietary supplements from Mexico?
- FDA records a charge code on every refused shipment line. For dietary supplements from Mexico the most frequent are UNAPPROVED (unapproved new drug, 697 lines), NO ENGLISH (required label information not in English, 421 lines) and NUTRIT LBL (nutrition information missing from label, 278 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 Mexico?
- As of October 25, 2026, the FDA import alerts for this category that list Mexico firms are Import Alert 54-16 (13 firms) and Import Alert 54-14 (12 firms). General food alerts numbered 99-xx can list Mexico firms too; see the country page.
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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.