Reference Source

HIMALAYA PVT LTD · 66-41 · INDIA

For HIMALAYA PVT LTD, 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 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 2026-10-01.

Firm
HIMALAYA PVT LTD 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
Makali 562 162 , Bengaluru, INDIA verified
Date published
06/09/2025 verified
Product code
53 E - - -- Hair Preps(Non-Coloring) | 66 V - - 99 Miscellaneous Patent Medicines, Etc. each item verified
Product
Himalaya Anti-Dandruff Tea Tree Shampoo | Himalaya Anti-Dandruff Tea Tree Shampoo 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): “…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…”. each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

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

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

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, Product and FDA notes

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…”.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

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