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FDA import refusals

FDA import refusals: dietary supplements from Uruguay

FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to September 27, 2018

FDA refused 4 dietary supplements shipment lines from Uruguay between October 2016 and September 27, 2018, 2 of them in 2018; the most refused products were herbals & botanical teas and multiple vitamins, most often for NO ENGLISH (required label information not in English).

Data from FDA public records, last checked .

4
dietary supplements lines refused since October 2016
2
refused so far in 2018
0
firms with the most records, listed below

Dietary supplements refusals from Uruguay by year

Shipment lines FDA refused each year. The table has the same numbers as the chart.
Bar chart: refusal lines by 2017 to 2018. The same numbers are in the table.00.511.522017: 2 refusal lines2’172018: 2 refusal lines2’18
Refusal lines by year
YearRefusal linesvs prior year
201820%
20172

Herbals & botanical teas refusals from Uruguay

FDA refused 1 herbals & botanical teas line from Uruguay between October 2016 and September 27, 2018, 25% of the dietary supplements lines.
Herbals & botanical teas product descriptions refused from Uruguay
FDA product descriptionLinesShare of dietary supplements
Herbals & botanical teas, n.e.c.125.0%

Recent herbals & botanical teas refusals

Recent Herbals & botanical teas refusals from Uruguay
DateFirmProductCharges
Apiarios Cabral Ltda.Montevideo, UruguayHerbals & botanical teas, n.e.cLIST INGRELACKS FIRMLACKS N/C+3Source

Multiple vitamins refusals from Uruguay

FDA refused 1 multiple vitamins line from Uruguay between October 2016 and September 27, 2018, 25% of the dietary supplements lines.
Multiple vitamins product descriptions refused from Uruguay
FDA product descriptionLinesShare of dietary supplements
Multiple vitamins (mvi-12 vitamin combo) (vitamin)125.0%

Recent multiple vitamins refusals

Recent Multiple vitamins refusals from Uruguay
DateFirmProductCharges
Immune GeneticsMontevideo, UruguayMultiple vitamins (mvi-12 vitamin combo) (vitamin)LABELINGSource

Potassium refusals from Uruguay

FDA refused 1 potassium line from Uruguay between October 2016 and September 27, 2018, 25% of the dietary supplements lines.
Potassium product descriptions refused from Uruguay
FDA product descriptionLinesShare of dietary supplements
Potassium (mineral)125.0%

Recent potassium refusals

Recent Potassium refusals from Uruguay
DateFirmProductCharges
UrufarmaMontevideo, UruguayPotassium (mineral)NO ENGLISHUNAPPROVEDSource

Other dietary supplements products refused from Uruguay

Products refused from Uruguay in dietary supplements
Product groupLinesShare
Vitamin b12125.0%

Why FDA refused dietary supplements from Uruguay

FDA records a charge code on each refused line; one line can carry several.
Most frequent refusal charges for dietary supplements from Uruguay
Charge codeMeaningLinesShare
NO ENGLISHRequired label information not in English327%
UNAPPROVEDUnapproved new drug218%
LABELINGFair Packaging and Labeling Act19%
LACKS FIRMManufacturer name and address missing19%
LACKS N/CNet quantity statement missing19%
LIST INGREIngredients not listed19%
NUTRIT LBLNutrition information missing from label19%
USUAL NAMECommon or usual name missing19%

Latest dietary supplements refusals from Uruguay

Latest FDA dietary supplements refusals from Uruguay
DateFirmProductCharges
Immune GeneticsMontevideo, UruguayMultiple vitamins (mvi-12 vitamin combo) (vitamin)LABELINGSource
Apiarios Cabral Ltda.Montevideo, UruguayHerbals & botanical teas, n.e.cLIST INGRELACKS FIRMLACKS N/C+3Source
UrufarmaMontevideo, UruguayVitamin b12 (cyanocobalamin)NO ENGLISHUNAPPROVEDSource
UrufarmaMontevideo, UruguayPotassium (mineral)NO ENGLISHUNAPPROVEDSource

Questions about dietary supplements refusals from Uruguay

How many dietary supplements shipments from Uruguay did FDA refuse in 2018?
FDA refused 2 shipment lines of dietary supplements from Uruguay in 2018 through September 27, 2018, compared with 2 in 2017.
Why does FDA refuse dietary supplements from Uruguay?
FDA records a charge code on every refused shipment line. For dietary supplements from Uruguay the most frequent are NO ENGLISH (required label information not in English, 3 lines), UNAPPROVED (unapproved new drug, 2 lines) and LABELING (Fair Packaging and Labeling Act, 1 line). A charge describes what FDA's reference table says about one shipment line, not about every firm.
Which import alerts cover dietary supplements from Uruguay?
As of October 26, 2026, no import alert numbered under this category lists a firm in Uruguay in SupplierRadar's records. General food alerts numbered 99-xx can still list Uruguay firms; 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.