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 Name	Location	Cases
1	NingBo Huize Commodity Co.,Ltd.	Yuyao, CHINA	29
2	Dr Irena Eris S.A.	Piaseczno, POLAND	16
3	Incosmo S.R.L	Biassono, ITALY	16
4	Emami Limited	Calcutta, INDIA	6
5	Macrovita	Nea Philadelphia, GREECE	6
6	Hemani International	Karachi, PAKISTAN	5
7	Nouvelle Parfumeria Gandour	Abidjan 01, IVORY COAS	5
8	Reckitt Benckiser Indonesia	Jakarta, INDONESIA	5
9	Protek	Korolevo, RUSSIA	5
10	4e De Mexico Sa De Cv	Naucalpan de Juarez, MEXICO	5
11	Csli Co Ltd	Shanghai, CHINA	4
12	TIL HEALTHCARE PVT LTD	Irugulam Post, INDIA	4
13	Parfums Christian Dior	Paris, FRANCE	4
14	Pharma Cosmetics Pty Ltd	Silverwater, AUSTRALIA	4
15	Glaxosmithkline	Brentford, UNITED KIN	3
16	Emami Limited "Epip Complex	Assam, INDIA	3
17	Laboratorios Vijosa, S.A. de C.V.	Antiguo Cuscatlan, EL SALVADO	3
18	Alcantara Espana Sa	Salamanca, SPAIN	3
19	Dabur India Limited	Silvassa, INDIA	3
20	Johnson & Johnson Gmbh Ltd	Maidenhead, UNITED KIN	3

Recent Import Refusals

Date	Product	Firm
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	MENTHOL (ANTI-PRURITIC) 62MAY08	Kestrel MedicalUNITED KIN
9/28/2023	MISCELLANEOUS PATENT MEDICINES, ETC. 66VBY99	MADATHIL EXPORTSINDIA
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	EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDL99	Emami Limited "Epip ComplexINDIA
1/11/2023	HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) 53ED01	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.