# Small Lab Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For Small Lab Co., Ltd. · 66-41 · KOREA (THE REPUBLIC OF), import alert is 66-41; import alert name is Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S; country is KOREA (THE REPUBLIC OF); product is ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM; product code is 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - -- Skin Care Prep | 64 X - - 06 Salicylic Acid (Keratolytic) | 64 X - - -- Keratolytic | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 05/08/2025; address is 243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** Small Lab Co., 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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 05/08/2025 _(verified: appears in the quote below)_
- **Product code:** 53 L - - 06 Moisturizing (Skin Care Preparations) | 53 L - - -- Skin Care Prep | 64 X - - 06 Salicylic Acid (Keratolytic) | 64 X - - -- Keratolytic | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM | ACNE SERUM _(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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. | 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. _(verified: each item appears in the quote below)_

## What the source says

> Small Lab Co., Ltd. Date Published : 05/08/2025 243-15 Tekeunojungang-Ro , Yuseong, Daejeon KOREA (THE REPUBLIC OF) 53 L - - 06 Moisturizing (Skin Care Preparations) Date Published: 05/08/2025 Desc: ACNE SERUM 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 53 L - - -- Skin Care Prep Date Published: 06/24/2026 Desc: ACNE SERUM 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 64 X - - 06 Salicylic Acid (Keratolytic) Date Published: 05/08/2025 Desc: ACNE SERUM 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 64 X - - -- Keratolytic Date Published: 06/24/2026 Desc: ACNE SERUM 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 05/08/2025 Desc: ACNE SERUM 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): “…Help brighten the appearance of dark spots and discoloration”, “…Visibly reduces acne & helps bring a more nourished complexion”.

## 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/).