Official recall, safety alert and import refusal records for cosmetics and sunscreens from Korea (MFDS), the EU (Safety Gate), the U.S. (FDA) and Canada (Health Canada). Has a Korean product had problems in other countries? Filter by “Made in South Korea”.
| Date | Product | Firm | Reason | ||
|---|---|---|---|---|---|
| Sep 23, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 23, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | BRAND501 CORP | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | OCTISALATE (ULTRAVIOLET SCREEN/SUNSCREEN) Made in South Korea | Kolmar Korea Co., Ltd. | NOT LISTED: Appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information available to the FDA, it appears that the drug... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Cosmax Inc | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 21, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 19, 2026 | US | HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 18, 2026 | US | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 18, 2026 | US | ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) Made in South Korea | Kolmar Korea Co., Ltd. | FRNMFGREG: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of... Import refusal | Source |
| Sep 16, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | MFR INSAN: The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Sep 16, 2026 | US | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. Made in South Korea | Seoul Cosmetics Co., Ltd. | MFR INSAN: The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Sep 16, 2026 | US | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. Made in South Korea | Seoul Cosmetics Co., Ltd. | MFR INSAN: The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Sep 10, 2026 | US | EYE LOTION (EYE MAKEUP PREPARATIONS) Made in South Korea | GDK Cosmetics Co., Ltd. | REFUSE EI: The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) Made in South Korea | K.Boeun Pharmaceutical Co.,Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) Made in South Korea | Dongkwang Pharm Co Ltd | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 9, 2026 | US | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 9, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Enprani Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 8, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Soleo Cosmetic CO.,LTD | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Sep 3, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmax Inc | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 3, 2026 | US | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. Made in South Korea | UNKNOWN | CSTIC LBLG: The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21... Import refusal | Source |
| Sep 2, 2026 | US | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 2, 2026 | US | EYE MAKEUP REMOVER (EYE MAKEUP PREPARATIONS) Made in South Korea | Cosmax Inc | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1). Import refusal | Source |
| Sep 2, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Cosmecca Korea Co., Ltd. | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Cosmecca Korea Co., Ltd. | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | COSMAX BTI | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. Made in South Korea | COSMAX BTI | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) Made in South Korea | CREAM COSMAX CO. LTD | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1). Import refusal | Source |
| Sep 2, 2026 | US | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | CREAM COSMAX CO. LTD | NO ENGLISH: Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1) Import refusal | Source |
| Sep 2, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 2, 2026 | US | MOISTURIZING (SKIN CARE PREPARATIONS) Made in South Korea | Cosmecca Korea Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Sep 1, 2026 | US | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. Made in South Korea | Seoul Cosmetics Co., Ltd. | CSTIC LBLG: The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21... Import refusal | Source |
| Aug 31, 2026 | US | OTHER SKIN CARE PREPARATIONS, N.E.C. Made in South Korea | Daewoong Pharmaceutical, Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Aug 28, 2026 | US | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. Made in South Korea | Seoul Cosmetics Co., Ltd. | REFUSE EI: The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Aug 28, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | REFUSE EI: The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or... Import refusal | Source |
| Aug 26, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Kolmar Korea Co., Ltd. | FRNMFGREG: The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of... Import refusal | Source |
| Aug 25, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Kolmar Korea Co. Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) Made in South Korea | Megacos Manufacturing Co., Ltd. | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Kolmar Korea Co. Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) Made in South Korea | Cosmecca Korea Co., Ltd. | NOT LISTED: Appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information available to the FDA, it appears that the drug... Import refusal | Source |
| Aug 25, 2026 | US | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Nowcos Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | HINATURE | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Kolmar Korea Co. Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 25, 2026 | US | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) Made in South Korea | MH AND COMPANY | CSTIC LBLG: The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21... Import refusal | Source |
| Aug 25, 2026 | US | HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) Made in South Korea | GREEN COS INC | UNAPPROVED: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section... Import refusal | Source |
| Aug 25, 2026 | US | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. Made in South Korea | Kolmar Korea Co. Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
| Aug 23, 2026 | US | TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) Made in South Korea | Seoul Cosmetics Co., Ltd. | DRUG GMPS: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture,... Import refusal | Source |
Sources: KR MFDS cosmetic recalls and sales suspensions (data.go.kr) · EU EU Safety Gate weekly reports, cosmetics alerts since 2015 (ec.europa.eu/safety-gate-alerts) · US FDA Enforcement Reports for sunscreens (openFDA) and FDA Import Refusal Reports for cosmetics and sunscreens made in South Korea (accessdata.fda.gov) · CA Health Canada Recalls and Safety Alerts open data (recalls-rappels.canada.ca). An import refusal means the shipment was refused entry at the U.S. border; it is not a recall of products already on sale. Country of origin is shown as the source records it; Health Canada's open data does not give one.