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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.
Bar chart: refusal lines by 2016 to 2026. The same numbers are in the table.01002003002016 (from October 1): 13 refusal lines’162017: 47 refusal lines’172018: 35 refusal lines’182019: 105 refusal lines’192020: 89 refusal lines’202021: 57 refusal lines’212022: 285 refusal lines285’222023: 97 refusal lines’232024: 146 refusal lines’242025: 127 refusal lines’252026 (year to date): 131 refusal lines131’26*
* 2026 is year to date, through October 8, 2026. FDA's refusal data starts on October 1, 2016, so 2016 covers three months.
Refusal lines by year
YearRefusal linesvs prior year
2026 (to date)131
2025127-13%
2024146+51%
202397-66%
2022285+400%
202157-36%
202089-15%
2019105+200%
201835-26%
201747
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.
Vitamin product descriptions refused from Mexico
FDA product descriptionLinesShare of dietary supplements
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.63255.8%
Vitamin, n.e.c.494.3%

Recent vitamin refusals

Recent Vitamin refusals from Mexico
DateFirmProductCharges
Omega NutritionHidalgo Del Parral, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cADDDRUGBIOSource
Merck, S.A. de C.V.Naucalpan De Juarez, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
RmUnknown, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource

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.
Herbals & botanicals product descriptions refused from Mexico
FDA product descriptionLinesShare of dietary supplements
Herbals & botanicals (not teas), n.e.c.877.7%

Recent herbals & botanicals refusals

Recent Herbals & botanicals refusals from Mexico
DateFirmProductCharges
Herbalfoods, S.A. de C.V.Guadalajara, MexicoHerbals & botanicals (not teas), n.e.cNEEDS FCENO PROCESSSource

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.
Vitamin c product descriptions refused from Mexico
FDA product descriptionLinesShare of dietary supplements
Vitamin c (ascorbic acid)423.7%

Recent vitamin c refusals

Recent Vitamin c refusals from Mexico
DateFirmProductCharges
Bayer de Mexico, S.A. de C.V.Lerma, MexicoVitamin c (ascorbic acid)UNAPPROVEDSource

Other dietary supplements products refused from Mexico

Products refused from Mexico in dietary supplements
Product groupLinesShare
Vitamin b12363.2%
Vitamin b1302.7%
Glucosamine hydrochloride221.9%
Multiple vitamins211.9%
Folic acid151.3%
Herbals & botanical teas111.0%

Why FDA refused dietary supplements from Mexico

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for dietary supplements from Mexico
Charge codeMeaningLinesShare
UNAPPROVEDUnapproved new drug69739%
NO ENGLISHRequired label information not in English42123%
NUTRIT LBLNutrition information missing from label27815%
LABELINGFair Packaging and Labeling Act1247%
NCONTACTNo U.S. adverse event contact on supplement label1036%
INCONSPICURequired information not conspicuous382%
DIETARYLBLNot identified as a dietary supplement362%
HEALTH CUnauthorized nutrient content or health claim352%
LACKS N/CNet quantity statement missing352%
FALSEFalse or misleading labeling332%

Import alerts for dietary supplements that list Mexico firms

Import alerts for dietary supplements listing firms in Mexico
AlertCoversRedGreen
54-16Foods/supplements with active pharmaceutical ingredient13
54-14Supplements from firms not meeting supplement GMP12

Mexico dietary supplements firms with the most FDA records

Counts are FDA records in SupplierRadar's data, not a ranking of quality.
Mexico dietary supplements firms with the most FDA records
FirmCityFDA records
Plantas Medicinales de MexicoDELEGACION XOCHIMILCO C.P171
Omega NutritionHidalgo Del Parral127
Tonic Life S de RLIrapuato34
Natural ProvidaGuadalajara24
Merck, S.A. de C.V.Naucalpan De Juarez22
Laboratorio y Red de Distribucion Vital Health S.A. de C.V.Hermosillo16
True HerbsMichoacan16
Herbolaris InternacionalZapopan15
Corporativo Serysi, S. De R.L. De C.V.Zapopan14
Laboratorios Tornel, S.A.Naucalpan13

Latest dietary supplements refusals from Mexico

Latest FDA dietary supplements refusals from Mexico
DateFirmProductCharges
MercNaucalpan De Juarez, MexicoVitamin b6 (pyridoxine)UNAPPROVEDSource
Bayer de Mexico, S.A. de C.V.Lerma, MexicoVitamin c (ascorbic acid)UNAPPROVEDSource
Herbalfoods, S.A. de C.V.Guadalajara, MexicoHerbals & botanicals (not teas), n.e.cNEEDS FCENO PROCESSSource
Laboratorio y Red de Distribucion Vital Health S.A. de C.V.Hermosillo, MexicoVitamin aFALSESource
Omega NutritionHidalgo Del Parral, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cADDDRUGBIOSource
Merck, S.A. de C.V.Naucalpan De Juarez, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
RmUnknown, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
El Dragon de Oro de la SaludCalle Ocampo 3 Guanaj, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
RmUnknown, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cDIETARYLBLNO ENGLISHNUTRIT LBLSource
Laboratorio Kimik BotanikZapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Laboratorios ShelaCoyoacan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHNUTRIT LBLSource
Best S ABenito Juarez, MexicoMultiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDSource
Merck, S.A. de C.V.Naucalpan De Juarez, MexicoVitamin b12 (cyanocobalamin)UNAPPROVEDSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource
Asesoria Y Desarrollo De Productos Naturistas, S.A. De C.V.Zapopan, MexicoVitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.cNO ENGLISHSource

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.