# YANG WOO BIO CO. LTD. · 66-41 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For YANG WOO BIO 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 Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs; product code is 54 F - - -- Herbal & Botanicals(other than teas) | 54 K - - -- Herbal & Botanicals(other than teas) II | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc; date published is 12/30/2019; address is Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** YANG WOO BIO 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:** Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 12/30/2019 _(verified: appears in the quote below)_
- **Product code:** 54 F - - -- Herbal & Botanicals(other than teas) | 54 K - - -- Herbal & Botanicals(other than teas) II | 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. | 66 V - - 99 Miscellaneous Patent Medicines, Etc. _(verified: each item appears in the quote below)_
- **Product:** Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs | Digest Soothe Granule Packs _(verified: each item appears in the quote below)_
- **FDA notes:** This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. | This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. _(verified: each item appears in the quote below)_

## What the source says

> YANG WOO BIO CO. LTD. Date Published : 12/30/2019 Dongsan-Myun , 175 Wonmudong-Gil; Dongsan-Myeon , Chuncheon, Gangwon KOREA (THE REPUBLIC OF) 54 F - - -- Herbal & Botanicals(other than teas) Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 54 K - - -- Herbal & Botanicals(other than teas) II Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 54 Y - - -- Vit/Min/Prot/Unconv Diet Spec N.E.C. Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'. 66 V - - 99 Miscellaneous Patent Medicines, Etc. Date Published: 12/30/2019 Desc: Digest Soothe Granule Packs Notes: This product appears to be an unapproved new drug as the product label includes disease claims such as (not an all-inclusive list): OUTER PACKAGE - 'The Fermented, high-enzyme fruits and soothing herbs gently coat the stomach and esophagus to relieve heartburn and acid reflux. . .'; 'Digest + Soothe immediately relieves Heartburn, Acid Reflux, Indigestion, Nausea, Stomach Ache. . .'; PRIMARY PACKAGE - 'Instant heartburn relief ... when experiencing heartburn or acid reflux...'.

## 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/).