FDA import refusals
FDA import refusals: dietary supplements from Argentina
FDA refused 25 dietary supplements shipment lines from Argentina between October 2016 and July 31, 2026, 3 of them in 2026; the most refused products were herbals & botanical teas and vitamin, most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 25
- dietary supplements lines refused since October 2016
- 3
- refused so far in 2026
- 2
- firms with the most records, listed below
Dietary supplements refusals from Argentina by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 3 | |
| 2025 | 11 | |
| 2023 | 4 | 0% |
| 2022 | 4 | |
| 2019 | 3 |
Herbals & botanical teas refusals from Argentina
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanical teas, n.e.c. | 9 | 36.0% |
Recent herbals & botanical teas refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Cooperativa Agricola de la Colonia Liebig Ltda.Colonia Liebig, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Las MariasCaba, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source |
Vitamin refusals from Argentina
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. | 8 | 32.0% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Laboratorio Elea Phoenix SALos Polvorines, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | HEALTH C | Source | |
| Laboratorio Elea Phoenix SALos Polvorines, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | HEALTH C | Source | |
| Molecular Dynamics SASBuenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Catalent Argentina S.A.I.C.Buenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Catalent Argentina S.A.I.C.Buenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from Argentina
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 4 | 16.0% |
Other dietary supplements products refused from Argentina
| Product group | Lines | Share |
|---|---|---|
| Arnica | 1 | 4.0% |
| Calcium | 1 | 4.0% |
| Folic acid | 1 | 4.0% |
| Vitamin c | 1 | 4.0% |
Why FDA refused dietary supplements from Argentina
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 13 | 28% |
| UNAPPROVED | Unapproved new drug | 10 | 21% |
| NUTRIT LBL | Nutrition information missing from label | 9 | 19% |
| NOT LISTED | Product not listed with FDA | 4 | 9% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 3 | 6% |
| NEW VET DR | Appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food,… | 3 | 6% |
| HEALTH C | Unauthorized nutrient content or health claim | 2 | 4% |
| 708LISTING | It has been determined the drug is not included in a list required by Section 510(j). | 1 | 2% |
| 708NEWANIM | The article has been determined to be a new animal drug without an approved new animal drug application. | 1 | 2% |
| DIETARYLBL | Not identified as a dietary supplement | 1 | 2% |
Import alerts for dietary supplements that list Argentina firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 54-16 | Foods/supplements with active pharmaceutical ingredient | 1 |
Argentina dietary supplements firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Hrenuk S.A. | Apostoles | 7 |
| Molecular Dynamics SAS | Buenos Aires | 1 |
Latest dietary supplements refusals from Argentina
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Catalent AngentinaBuenos Aires, Argentina | Vitamin c (ascorbic acid) | NOT LISTEDNO ENGLISH | Source | |
| Laboratorio de Especialidades VeMunro, Argentina | Folic acid (vitamin) | NO ENGLISHNEW VET DR | Source | |
| Laboratorio de Especialidades VeMunro, Argentina | Calcium (mineral) | NO ENGLISHNEW VET DR | Source | |
| Cooperativa Agricola de la Colonia Liebig Ltda.Colonia Liebig, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Las MariasCaba, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Hrenuk S.A.Apostoles, Argentina | Herbals & botanical teas, n.e.c | NO ENGLISHNUTRIT LBL | Source | |
| Laboratorio Elea Phoenix SALos Polvorines, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | HEALTH C | Source | |
| Laboratorio Elea Phoenix SALos Polvorines, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | HEALTH C | Source | |
| Molecular Dynamics SASBuenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Ec Labs SACordoba, Argentina | Arnica (herbal & botanicals, not teas) | 708NEWANIM708LISTINGNEW VET DR+1 | Source | |
| Catalent Argentina S.A.I.C.Buenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Catalent Argentina S.A.I.C.Buenos Aires, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Idraet SRLCarapachay, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Idraet SRLCarapachay, Argentina | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Questions about dietary supplements refusals from Argentina
- How many dietary supplements shipments from Argentina did FDA refuse in 2026?
- FDA refused 3 shipment lines of dietary supplements from Argentina in 2026 through July 31, 2026, compared with 11 in 2025.
- Why does FDA refuse dietary supplements from Argentina?
- FDA records a charge code on every refused shipment line. For dietary supplements from Argentina the most frequent are NO ENGLISH (required label information not in English, 13 lines), UNAPPROVED (unapproved new drug, 10 lines) and NUTRIT LBL (nutrition information missing from label, 9 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 Argentina?
- As of October 26, 2026, the FDA import alerts for this category that list Argentina firms are Import Alert 54-16 (1 firm). General food alerts numbered 99-xx can list Argentina firms too; see the country page.
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