# HIMALAYA PVT LTD · 66-41 · INDIA — FDA import alert red lists: firms subject to detention without physical examination

For HIMALAYA PVT LTD · 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 Anti-Dandruff Tea Tree Shampoo | Himalaya Anti-Dandruff Tea Tree Shampoo; product code is 53 E - - -- Hair Preps(Non-Coloring) | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 06/09/2025; address is Makali 562 162 , Bengaluru, INDIA, verified against its source on 2026-09-16.

- **Firm:** HIMALAYA PVT LTD _(verified: appears in the quote below)_
- **Import alert:** 66-41
- **Import alert name:** Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
- **Country:** INDIA _(verified: appears in the quote below)_
- **Address:** Makali 562 162 , Bengaluru, INDIA _(verified: appears in the quote below)_
- **Date published:** 06/09/2025 _(verified: appears in the quote below)_
- **Product code:** 53 E - - -- Hair Preps(Non-Coloring) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Himalaya Anti-Dandruff Tea Tree Shampoo | Himalaya Anti-Dandruff Tea Tree Shampoo _(verified: each item appears in the quote below)_
- **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): “…Anti-Dandruff TEA TREE SHAMPOO” “…Tea Tree Oil A natural anti-fungal agent known to fight dandruff…”. | 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…”. _(verified: each item appears in the quote below)_

## What the source says

> HIMALAYA PVT LTD Date Published : 06/09/2025 Makali 562 162 , Bengaluru, INDIA 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…”. 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…”.

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_190.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).