HIMALAYA WELLNESS COMPANY · 66-41 · INDIA
For HIMALAYA WELLNESS COMPANY, import alert is 66-41; country is INDIA; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; product is Himalaya Liv.52 Syrup | Himalaya Septilin Tablets | Himalaya Cystone Tablets | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Septilin Tablets | Himalaya Cystone Tablets; product code is 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 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 listed 4 times: 01/04/2024, 06/02/2025, 01/06/2025 and 10/25/2010; address is listed 4 times: Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA, 2 Plot No - 5 , Unit - Iii; Plant No; Apparel Park Cum Industrial Area , Katha, Himachal Pradesh INDIA, Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli,Tavarekere Road , Off NH-4 , Nelamangala Taluk, Bengaluru Rural INDIA and NH4, Makali, Tumkur Road , opposite to JCB , Bengaluru, Karnataka INDIA, verified against its source on 2026-10-01.
- 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
- 2 Plot No - 5 , Unit - Iii; Plant No; Apparel Park Cum Industrial Area , Katha, Himachal Pradesh INDIA also listed
- Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli,Tavarekere Road , Off NH-4 , Nelamangala Taluk, Bengaluru Rural INDIA also listed
- NH4, Makali, Tumkur Road , opposite to JCB , Bengaluru, Karnataka INDIA also listed
- Date published
- 01/04/2024 verified
- 06/02/2025 also listed
- 01/06/2025 also listed
- 10/25/2010 also listed
- Product code
- 54 F - - -- Herbal & Botanicals(other than teas) | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 54 F - - 99 Herbals & Botanicals (not Teas), N.E.C. | 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 Liv.52 Syrup | Himalaya Septilin Tablets | Himalaya Cystone Tablets | Himalaya Liv.52 Syrup | Himalaya Liv.52 Syrup | Himalaya Septilin Tablets | Himalaya Cystone 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
What the source says
HIMALAYA WELLNESS COMPANY Date Published : 01/04/2024 Plt.No.687,Phase 3,Vasa , Industrial Area,Kiadb, INDIA
— accessdata.fda.gov, retrieved 2026-09-24
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
54 F - - -- Herbal & Botanicals(other than teas) Date Published: 01/04/2024 Desc: Himalaya Liv.52 Syrup 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 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 Septilin Tablets 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 01/06/2025 Desc: Himalaya Cystone Tablets
— all from accessdata.fda.gov, retrieved 2026-09-24
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
— accessdata.fda.gov, retrieved 2026-09-15
Product code
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].”
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
— accessdata.fda.gov, retrieved 2026-09-24
Product code
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: 01/06/2025 Desc: Himalaya Liv.52 Tablets 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/11/2025 Desc: Karela Tablets (Bitter Gourd) 66 Y - - 99 Exhibits - Other Drug Related Items N.E.C. Date Published: 01/06/2025 Desc: Himalaya Liv.52 Tablets
The same source also states
Himalaya Wellness Company Date Published : 10/25/2010 NH4, Makali, Tumkur Road , opposite to JCB , Bengaluru, Karnataka INDIA
— accessdata.fda.gov, retrieved 2026-09-24
Product code
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: 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: 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: 01/23/2026 Desc: Diabecon
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_190.html
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