ImportRefusal LogoImportRefusal

Violation Code: 178

FDA Violation

Charge Code: COL ADDED

351
Total Refusals
195
Affected Firms
11/21/2025
Latest Case
5/13/2002
First Case

Violation Details

Violation Code (ASC ID)
178
Charge Code
COL ADDED
Description
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Legal Section
501(a)(4)(A), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1NingBo Huize Commodity Co.,Ltd.Yuyao, CHINA29
2Incosmo S.R.LBiassono, ITALY16
3Dr Irena Eris S.A.Piaseczno, POLAND16
4Emami LimitedCalcutta, INDIA6
5MacrovitaNea Philadelphia, GREECE6
6Nouvelle Parfumeria GandourAbidjan 01, IVORY COAS5
7ProtekKorolevo, RUSSIA5
8Reckitt Benckiser IndonesiaJakarta, INDONESIA5
94e De Mexico Sa De CvNaucalpan de Juarez, MEXICO5
10Hemani InternationalKarachi, PAKISTAN5
11Pharma Cosmetics Pty LtdSilverwater, AUSTRALIA4
12Parfums Christian DiorParis, FRANCE4
13Csli Co LtdShanghai, CHINA4
14TIL HEALTHCARE PVT LTDIrugulam Post, INDIA4
15Dabur India LimitedSilvassa, INDIA3
16Profrance EuBogota, COLOMBIA3
17Bio-Scientific Ind. De Cosm.LtdaSao Paulo, BRAZIL3
18Jordan Co., For Dead Sea ProductAlshmisanee, JORDAN3
19GlaxosmithklineBrentford, UNITED KIN3
20Cholayil PVT LTDSidcul, INDIA3

Recent Import Refusals

DateProductFirm
11/21/2025
MISCELLANEOUS PATENT MEDICINES, ETC.
66VDY99
Guangzhou QingMang Biotechnology Co., LtdCHINA
12/3/2024
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54YCR99
Kunming Aoqun Bio-Tech Co,. LtdCHINA
9/26/2024
CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
61XBL14
TIL HEALTHCARE PVT LTDINDIA
9/3/2024
MISCELLANEOUS PATENT MEDICINES, ETC.
66VBY99
RAINBOW PASSIONINDIA
2/14/2024
MISCELLANEOUS PATENT MEDICINES, ETC.
66VAY99
Reckitt Benckiser (India) Pvt. Ltd.INDIA
9/28/2023
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JY01
Reckitt BenckiserINDIA
9/28/2023
MISCELLANEOUS PATENT MEDICINES, ETC.
66VBY99
MADATHIL EXPORTSINDIA
9/28/2023
MENTHOL (ANTI-PRURITIC)
62MAY08
Kestrel MedicalUNITED KIN
8/31/2023
OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
53EC99
Ramkrishna Vidyut Ayurvedic Pharmacy, Pune(M.S.)INDIA
3/24/2023
ANTI-MICROBIAL N.E.C.
62HAL99
Brands International CorporationCANADA
3/9/2023
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YBA99
Belmed Preparaty RUEBELARUS
1/11/2023
HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
53ED01
Emami Limited "Epip ComplexINDIA
1/11/2023
HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
53ED01
Emami Limited "Epip ComplexINDIA
1/11/2023
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YDL99
Emami Limited "Epip ComplexINDIA
12/15/2022
MISCELLANEOUS PATENT MEDICINES, ETC.
66VBY99
Casmara Cosmetics, S.A.SPAIN

Frequently Asked Questions

What is FDA violation code 178?

178 is an FDA violation code that indicates: "The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).". This violation is based on 501(a)(4)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 178?

According to FDA Import Refusal data, there have been 351 import refusals issued for violation code 178, affecting 195 unique firms.

When was the most recent refusal for violation 178?

The most recent import refusal for violation 178 was on November 21, 2025.

What products are commonly refused for violation 178?

Products commonly refused under violation 178 include: MISCELLANEOUS PATENT MEDICINES, ETC., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., CYPROHEPTADINE HCL (ANTI-HISTAMINIC). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 178?

Violation code 178 is based on 501(a)(4)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.