Himalaya Wellness Company
FDA import alert and refusal historyBengaluru, IndiaFEI 3004259394
As of October 26, 2026, Himalaya Wellness Company is not on any FDA import alert in SupplierRadar's records; FDA refused 10 of its shipment lines between January 19, 2023 and September 18, 2026, most often for unapproved new drug (UNAPPROVED).
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- Not listed
- Last import refusal
- Herbals & botanicals (not teas), n.e.c. · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- Classified VAI (Voluntary Action Indicated)
Every FDA record for Himalaya Wellness Company
13 records, newest first. Each line links to the FDA page it came from.
2026
- Import refusalRefused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry AEK-2012048-0Source
2025
- Import refusalRefused, Ashwagandha (herbal & botanical teas)UNAPPROVEDEntry 799-9454876-8Source
- Import refusalRefused, Dietary conventional foods, n.e.c.UNAPPROVEDEntry AEK-8499498-5Source
- Import refusalRefused, Foods with supplemental nutrients added, with or without artifical sweetnersUNAPPROVEDEntry 799-6115799-8Source
- Import refusalRefused, Herbals & botanicals (not teas), n.e.c.UNAPPROVEDEntry 799-5215033-3Source
2024
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-3812437-8Source
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and EconSource
- Import refusalRefused, Amla (herbal & botanicals ii)UNAPPROVEDEntry AEK-4613827-5Source
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry KM6-3610029-9Source
2023
- Import refusalRefused, Noni (herbal & botanicals, not teas)UNAPPROVEDEntry AEK-3539186-9Source
- Import refusalRefused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-2651723-3Source
2016
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and EconSource
2014
- InspectionInspection classified VAI (Voluntary Action Indicated)Food Composition, Standards, Labeling and EconSource
Refusal charges, in plain English
- UNAPPROVED10 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
Questions about Himalaya Wellness Company
- Is Himalaya Wellness Company on an FDA import alert?
- No listing for Himalaya Wellness Company appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the India page.
- Has FDA refused shipments from Himalaya Wellness Company?
- Yes. FDA refused 10 shipment lines from Himalaya Wellness Company between January 19, 2023 and September 18, 2026. The most recent, on September 18, 2026, was herbals & botanicals (not teas), n.e.c., charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Himalaya Wellness Company's shipments?
- The most frequent charge is UNAPPROVED (unapproved new drug, 10 lines).
- When was Himalaya Wellness Company last inspected by FDA?
- FDA's most recent inspection of Himalaya Wellness Company with a final classification is dated May 24, 2024 and was classified VAI (Voluntary Action Indicated).
- What is Himalaya Wellness Company's FEI number?
- Himalaya Wellness Company's FDA Establishment Identifier (FEI) is 3004259394.
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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.