FDA import refusals
FDA import refusals: dietary supplements from India
FDA category: Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties · October 2016 to October 8, 2026
FDA refused 1,748 dietary supplements shipment lines from India between October 2016 and October 8, 2026, 398 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 .
- 1,748
- dietary supplements lines refused since October 2016
- 398
- refused so far in 2026
- 10
- firms with the most records, listed below
Dietary supplements refusals from India 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) | 398 | |
| 2025 | 351 | +46% |
| 2024 | 241 | +72% |
| 2023 | 140 | +40% |
| 2022 | 100 | -29% |
| 2021 | 140 | +41% |
| 2020 | 99 | +8% |
| 2019 | 92 | +18% |
| 2018 | 78 | -2% |
| 2017 | 80 | |
| 2016 (from Oct) | 29 |
Vitamin refusals from India
FDA refused 576 vitamin lines from India between October 2016 and October 8, 2026, 33% 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. | 468 | 26.8% |
| Vitamin, n.e.c. | 108 | 6.2% |
Recent vitamin refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| SBL Private LimitedEast Delhi, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| BioticslifeBengaluru, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Gufic Biosciences LtdMumbai, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source |
Herbals & botanicals refusals from India
FDA refused 526 herbals & botanicals lines from India between October 2016 and October 8, 2026, 30% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Herbals & botanicals (not teas), n.e.c. | 526 | 30.1% |
Recent herbals & botanicals refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Ramdev Food Products Pvt LtdChangodar, India | Herbals & botanicals (not teas), n.e.c | SALMONELLA | Source | |
| Sheth BrothersBhavnagar, India | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Sheth BrothersBhavnagar, India | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Handa Health Care CenterCivil Lines, India | Herbals & botanicals (not teas), n.e.c | NOT LISTEDUNAPPROVED | Source |
Ashwagandha refusals from India
FDA refused 101 ashwagandha lines from India between October 2016 and October 8, 2026, 6% of the dietary supplements lines.
| FDA product description | Lines | Share of dietary supplements |
|---|---|---|
| Ashwagandha (herbal & botanicals, not teas) | 101 | 5.8% |
Recent ashwagandha refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Himalaya Wellness CompKora Hobli Tumakuru, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Everest AyurvedaKerala, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source |
Other dietary supplements products refused from India
| Product group | Lines | Share |
|---|---|---|
| Moringa oleifera contd | 45 | 2.6% |
| Multiple vitamins | 33 | 1.9% |
| Mecobalamin | 30 | 1.7% |
| Herbals & botanical teas | 29 | 1.7% |
| Kratom | 23 | 1.3% |
| Vitamin b1 | 21 | 1.2% |
Why FDA refused dietary supplements from India
FDA records a charge code on each refused line; one line can carry several.
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| UNAPPROVED | Unapproved new drug | 1,245 | 60% |
| NUTRIT LBL | Nutrition information missing from label | 225 | 11% |
| NCONTACT | No U.S. adverse event contact on supplement label | 132 | 6% |
| NOT LISTED | Product not listed with FDA | 107 | 5% |
| DIETARYLBL | Not identified as a dietary supplement | 101 | 5% |
| LIST INGRE | Ingredients not listed | 80 | 4% |
| FRNMFGREG | Appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured,… | 54 | 3% |
| UNSAFE COL | Color additive unsafe under section 721 | 54 | 3% |
| FALSE | False or misleading labeling | 49 | 2% |
| LABELING | Fair Packaging and Labeling Act | 42 | 2% |
Import alerts for dietary supplements that list India firms
India 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 |
|---|---|---|
| Marudhar Impex | Ahmedabad | 69 |
| Sheth Brothers | Bhavnagar | 35 |
| Ancient Greenfields | Coimbatore | 32 |
| Patanjali Ayurved Limited | Haridwar | 30 |
| Til Healthcare Pvt Ltd | Irugulam Post | 25 |
| Vahdam Teas Pvt Lt | Noida | 25 |
| Zenith Drinks Pvt Ltd | New Delhi | 24 |
| Krm Ayurveda Pvt Ltd | North West Delhi | 21 |
| Goodcare Pharma Pvt. Ltd. | West Bengal | 18 |
| Planet Ayurveda Private Limited | Sas Nagar (Mohali) | 17 |
Latest dietary supplements refusals from India
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Himalaya Wellness CompKora Hobli Tumakuru, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| SBL Private LimitedEast Delhi, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Winnexa Health Science Pvt LtdIndore, India | Probiotics (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Everest AyurvedaKerala, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Vaidyaratnam Oushadhasala Pvt LtdThrissur, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Harisre AyurvedicsPanthalloor, India | Ashwagandha (herbal & botanicals, not teas) | UNAPPROVED | Source | |
| Ramdev Food Products Pvt LtdChangodar, India | Herbals & botanicals (not teas), n.e.c | SALMONELLA | Source | |
| Aimil Pharmaceuticals IndiaNew Delhi, India | Cocculus | UNAPPROVED | Source | |
| Sheth BrothersBhavnagar, India | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Sheth BrothersBhavnagar, India | Herbals & botanicals (not teas), n.e.c | UNAPPROVED | Source | |
| Handa Health Care CenterCivil Lines, India | Herbals & botanicals (not teas), n.e.c | NOT LISTEDUNAPPROVED | Source | |
| Agusto Formulation Pvt LtdGujarat, India | Coenzyme q10 (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.) | NOT LISTEDUNAPPROVED | Source | |
| BioticslifeBengaluru, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Gufic Biosciences LtdMumbai, India | Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c | UNAPPROVED | Source | |
| Alkem Laboratories LtdMumbai, India | Folic acid (vitamin) | UNAPPROVED | Source | |
| Intas Pharmaceuticals LtdAhmedabad, India | Vitamin d2 (calciferol) | UNAPPROVED | Source | |
| Abott HealthcareSolan, India | Vitamin c (ascorbic acid) | UNAPPROVED | Source |
Questions about dietary supplements refusals from India
- How many dietary supplements shipments from India did FDA refuse in 2026?
- FDA refused 398 shipment lines of dietary supplements from India in 2026 through October 8, 2026, compared with 351 in 2025.
- Why does FDA refuse dietary supplements from India?
- FDA records a charge code on every refused shipment line. For dietary supplements from India the most frequent are UNAPPROVED (unapproved new drug, 1,245 lines), NUTRIT LBL (nutrition information missing from label, 225 lines) and NCONTACT (no U.S. adverse event contact on supplement label, 132 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 India?
- As of October 26, 2026, the FDA import alerts for this category that list India firms are Import Alert 54-14 (8 firms) and Import Alert 54-16 (2 firms). General food alerts numbered 99-xx can list India 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.