Reference Source

HIMALAYA WELLNESS COMPANY · 66-41 · INDIA

For HIMALAYA WELLNESS COMPANY · 66-41 · INDIA, import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is INDIA; product is Himalaya Septilin Tablets | Himalaya Cystone Tablets | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Cystone Tablets | Himalaya Septilin Tablets; product code is 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 01/04/2024; address is Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA, verified against its source on 2026-09-16.

Firm
HIMALAYA WELLNESS COMPANY verified
Import alert
66-41
Import alert name
Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
Country
INDIA verified
Address
Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA verified
Date published
01/04/2024 verified
Product code
54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - -- Herbal & Botanicals(other than teas) | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Himalaya Septilin Tablets | Himalaya Cystone Tablets | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Cystone Tablets | Himalaya Septilin Tablets each item verified
FDA notes
This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Neem, well-known for its anti-bacterial properties, helps protect skin from germs. Turmeric known for its antiseptic properties, helps protect skin…” [from the product label], “KILLS 99.9% GERMS” [from the product label].” | This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Neem, well-known for its anti-bacterial properties, helps protect skin from germs. Turmeric known for its antiseptic properties, helps protect skin…” [from the product label], “KILLS 99.9% GERMS” [from the product label].” also on this page
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

HIMALAYA WELLNESS COMPANY Date Published : 01/04/2024 Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/06/2025 Desc: Himalaya Septilin Tablets 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/06/2025 Desc: Himalaya Cystone Tablets 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 01/04/2024 Desc: Himalaya Liv.52 Syrup 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 01/04/2024 Desc: Himalaya Liv.52 Syrup 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/04/2024 Desc: Himalaya Liv.52 Syrup 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/06/2025 Desc: Himalaya Cystone Tablets 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/06/2025 Desc: Himalaya Septilin Tablets

accessdata.fda.gov, retrieved 2026-09-15

The same source also states

HIMALAYA WELLNESS COMPANY Date Published : 06/02/2025 2 Plot No - 5 , Unit - Iii; Plant No; Apparel Park Cum Industrial Area , Katha, Himachal Pradesh INDIA 53 J - - 01 Bath Soaps and Detergents (not Antiperspirant) (Personal Cleanliness) Date Published: 06/02/2025 Desc: HIMALAYA NEEM AND TURMERIC SOAP Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Neem, well-known for its anti-bacterial properties, helps protect skin from germs. Turmeric known for its antiseptic properties, helps protect skin…” [from the product label], “KILLS 99.9% GERMS” [from the product label].” 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/02/2025 Desc: HIMALAYA NEEM AND TURMERIC SOAP Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Neem, well-known for its anti-bacterial properties, helps protect skin from germs. Turmeric known for its antiseptic properties, helps protect skin…” [from the product label], “KILLS 99.9% GERMS” [from the product label].”

accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Himalaya Wellness Company Date Published : 01/06/2025 Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli,Tavarekere Road , Off NH-4 , Nelamangala Taluk, Bengaluru Rural INDIA 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 01/06/2025 Desc: Himalaya Liv.52 Tablets 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 12/11/2025 Desc: Karela Tablets (Bitter Gourd) 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/11/2025 Desc: Karela Tablets (Bitter Gourd) 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/06/2025 Desc: Himalaya Liv.52 Tablets 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 01/06/2025 Desc: Himalaya Liv.52 Tablets

accessdata.fda.gov, retrieved 2026-09-15

The same source also states

Himalaya Wellness Company Date Published : 10/25/2010 NH4, Makali, Tumkur Road , opposite to JCB , Bengaluru, Karnataka INDIA 41 Y - - 99 Dietary Conventional Foods, N.E.C. Date Published: 01/23/2026 Desc: Diabecon 53 E - - -- Hair Preps(Non-Coloring) Date Published: 06/09/2025 Desc: Himalaya Anti-Dandruff Tea Tree Shampoo Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. 53 J - - 99 Other Personal Cleanliness Products (not Antiperspirant), N.E.C. Date Published: 01/30/2015 Desc: Neem Face Wash 53 L - - 03 Face,Body,and Hand (excluding Shaving Preparations) (Skin Care Preparations) Date Published: 01/30/2015 Desc: Neem Face Wash 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 10/19/2015 Desc: Anti-Hair Fall Hair Oil 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. Date Published: 10/25/2010 Desc: Diaget Guard Granules Himalaya Diabecon Notes: India; 1/23/2007 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 10/25/2010 Desc: Diaget Guard Granules Himalaya Diabecon Notes: India; 1/23/2007 54 Y - - 99 Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C. Date Published: 01/23/2026 Desc: Diabecon 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 06/09/2025 Desc: Himalaya Anti-Dandruff Tea Tree Shampoo Notes: This product appears to be an unapproved new drug as defined by section 201(p) of the FD&C Act, 21 U.S.C. 321(p) as the product labeling and website includes statements such as (not an all-inclusive list): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/30/2015 Desc: Neem Face Wash 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 10/19/2015 Desc: Anti-Hair Fall Hair Oil 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/23/2026 Desc: Diabecon

accessdata.fda.gov, retrieved 2026-09-15

Source

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