FDA import refusals
FDA import refusals: dietary supplements from Guatemala
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 9, 2026
FDA refused 258 dietary supplements shipment lines from Guatemala between October 2016 and October 9, 2026, 130 of them in 2026; the most refused products were vitamin and vitamin b12, most often for UNAPPROVED (unapproved new drug).
Data from FDA public records, last checked .
- 258
- dietary supplements lines refused since October 2016
- 130
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from Guatemala 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) | 130 | |
| 2025 | 80 | +264% |
| 2024 | 22 | |
| 2022 | 2 | +100% |
| 2021 | 1 | -91% |
| 2020 | 11 | |
| 2018 | 9 | +350% |
| 2017 | 2 | |
| 2016 (from Oct) | 1 |
Vitamin refusals from Guatemala
FDA refused 69 vitamin lines from Guatemala between October 2016 and October 9, 2026, 27% 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. | 44 | 17.1% |
| Vitamin, n.e.c. | 25 | 9.7% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Santa FeColonia Valle, Guatemala | Vitamin, n.e.c | UNAPPROVED | Source | |
| UnknownUNKNOWN, Guatemala | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Laboratorio Industrial San CristobalSan Cristobal, Guatemala | Vitamin, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| Laboratorios LopezGuatemala, Guatemala | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Vitamin b12 refusals from Guatemala
FDA refused 36 vitamin b12 lines from Guatemala between October 2016 and October 9, 2026, 14% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin b12 (cyanocobalamin) | 36 | 14.0% |
Recent vitamin b12 refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| American VitalabNa, Guatemala | Vitamin b12 (cyanocobalamin) | RXLABELLABELING | Source | |
| Piersan Centroamericana, S.A.Unknown, Guatemala | Vitamin b12 (cyanocobalamin) | LACKS FIRMRXLABELLABELING | Source | |
| Merck S AMixco, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Diprofam LaboratoriesVilla Nueva, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Farmamedica, S.A.Guatemala, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source |
Vitamin c refusals from Guatemala
FDA refused 23 vitamin c lines from Guatemala between October 2016 and October 9, 2026, 9% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Vitamin c (ascorbic acid) | 23 | 8.9% |
Recent vitamin c refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| ConamepNueva, Guatemala | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Med Pharma LaboratoriesGuatemala, Guatemala | Vitamin c (ascorbic acid) | UNAPPROVED | Source |
Other dietary supplements products refused from Guatemala
| Product group | Lines | Share |
|---|---|---|
| Vitamin b1 | 21 | 8.1% |
| Vitamin a | 15 | 5.8% |
| Multiple vitamins | 13 | 5.0% |
| Vitamin b6 | 12 | 4.7% |
| Vitamin e | 11 | 4.3% |
| Ashwagandha | 7 | 2.7% |
Why FDA refused dietary supplements from Guatemala
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 229 | 71% |
| NO ENGLISH | Required label information not in English | 42 | 13% |
| NOT LISTED | Product not listed with FDA | 18 | 6% |
| LABELING | Fair Packaging and Labeling Act | 14 | 4% |
| NUTRIT LBL | Nutrition information missing from label | 11 | 3% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 3 | 1% |
| LACKS FIRM | Manufacturer name and address missing | 2 | 1% |
| RXLABEL | The labeling fails to bear, at a minimum, the symbol "RX Only". | 2 | 1% |
| DIETARYLBL | Not identified as a dietary supplement | 1 | 0% |
| HEALTH C | Unauthorized nutrient content or health claim | 1 | 0% |
Guatemala 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 |
|---|---|---|
| Farmamedica, S.A. | Guatemala | 9 |
| Laboratorios Farkot, S.A. | Guatemala City | 8 |
| Laboratorios y Drogueria Donovan | Guatemala | 8 |
| Drogueria y Laboratorios Roland | Guatemala | 8 |
| Bayer S.A. | Guatemala | 7 |
| Quinfica Nutramedics Boldo | Guatemala | 7 |
| Donovan Werke | Guatemala | 7 |
| Farmamedica de Guatemala SA | Colonia Santa Mareia | 7 |
| Merck S A | Mixco | 6 |
| Farmamedica SA | Guatemala | 6 |
Latest dietary supplements refusals from Guatemala
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| SelectepharmaMixco, Guatemala | Mecobalamin (vitamin) | UNAPPROVED | Source | |
| Farmamedica, S.A.Guatemala, Guatemala | Vitamin b1 (thiamine) | LABELING | Source | |
| American VitalabNa, Guatemala | Vitamin b12 (cyanocobalamin) | RXLABELLABELING | Source | |
| Piersan Centroamericana, S.A.Unknown, Guatemala | Vitamin b12 (cyanocobalamin) | LACKS FIRMRXLABELLABELING | Source | |
| Lab LafageBofasa, Guatemala | Vitamin e (tocopherol) | UNAPPROVED | Source | |
| Santa FeColonia Valle, Guatemala | Vitamin, n.e.c | UNAPPROVED | Source | |
| ConamepNueva, Guatemala | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Merck S AMixco, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| UnknownUNKNOWN, Guatemala | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | NO ENGLISH | Source | |
| Laboratorio Industrial San CristobalSan Cristobal, Guatemala | Vitamin, n.e.c | DIETARYLBLNO ENGLISH | Source | |
| ConamepNueva, Guatemala | Vitamin b1 (thiamine) | NO ENGLISH | Source | |
| Diprofam LaboratoriesVilla Nueva, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Med Pharma LaboratoriesGuatemala, Guatemala | Vitamin c (ascorbic acid) | UNAPPROVED | Source | |
| Laboratorios LopezGuatemala, Guatemala | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Supharma SA LaboratoryGuatemala, Guatemala | Ginseng (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Genoma Lab GuatemalaGuatemala, Guatemala | Vitamin b6 (pyridoxine) | UNAPPROVED | Source | |
| Farmamedica, S.A.Guatemala, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Laboratories Global FarmaGuatemala, Guatemala | Vitamin b12 (cyanocobalamin) | UNAPPROVED | Source | |
| Merck S AMixco, Guatemala | Vitamin b1 (thiamine) | LACKS FIRM | Source | |
| Merck S AMixco, Guatemala | Ashwagandha (herbal & botanicals, not teas) | NOT LISTEDUNAPPROVED | Source |
Questions about dietary supplements refusals from Guatemala
- How many dietary supplements shipments from Guatemala did FDA refuse in 2026?
- FDA refused 130 shipment lines of dietary supplements from Guatemala in 2026 through October 9, 2026, compared with 80 in 2025.
- Why does FDA refuse dietary supplements from Guatemala?
- FDA records a charge code on every refused shipment line. For dietary supplements from Guatemala the most frequent are UNAPPROVED (unapproved new drug, 229 lines), NO ENGLISH (required label information not in English, 42 lines) and NOT LISTED (product not listed with FDA, 18 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 Guatemala?
- As of October 26, 2026, no import alert numbered under this category lists a firm in Guatemala in SupplierRadar's records. General food alerts numbered 99-xx can still list Guatemala 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.