Violation Code: 64
FDA Violation
Charge Code: YELLOW #5
Violation Details
- Violation Code (ASC ID)
- 64
- Charge Code
- YELLOW #5
- Description
- The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
- Legal Section
- 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Unique Fragrances | Sonepat, INDIA | 31 |
| 2 | BRITANNIA INDUSTRIES LIMITED | Kolkata, INDIA | 28 |
| 3 | Ontario Impex of Canada Ltd. | Brampton, CANADA | 24 |
| 4 | Nestle Trading(Fiji) Ltd | Lami, FIJI | 22 |
| 5 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 17 |
| 6 | LIANYUNGANG YUNZHIBAO FOODSTUFF CO.,LTD. | Lianyungang, CHINA | 14 |
| 7 | Ramdev Food Products Pvt Ltd | Changodar, INDIA | 13 |
| 8 | Hardip Narayan & Sons Ltd. | Tumbairata, FIJI | 13 |
| 9 | REGENT FOODS CORPORATION | Metro Manila, PHILIPPINE | 13 |
| 10 | INTERFOOD SHAREHOLDING COMPANY | Bien Hoa, VIETNAM | 12 |
| 11 | SUBHI FAKHOURY EXP. EST | Amman, JORDAN | 12 |
| 12 | ALWAWAFED CO FOR FOOD INDUSTRIESAND JUICE | Nablus | 11 |
| 13 | EXPORTACIONES SAN MIGUEL AXUTLA S.A. DE C.V. | Heroica Puebla De Zaragoza, MEXICO | 11 |
| 14 | Royal Family Food | Nantou City, TAIWAN | 10 |
| 15 | Rico Food Industries Sdn. Bhd. | Kulim, MALAYSIA | 9 |
| 16 | Liwayway Marketing Corporation | Imus, PHILIPPINE | 9 |
| 17 | Shang Dao Food Co Ltd | Taipei, TAIWAN | 9 |
| 18 | Foster Clark Products Ltd. | San Gwann, MALTA | 9 |
| 19 | SABRITAS, S.de R.L. de C.V. | Ciudad De Mexico, MEXICO | 8 |
| 20 | HALDIRAM BHUJIAWALA LTD | Kolkata, INDIA | 8 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/14/2026 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EFT05 | Mars, IncorporatedUNITED STA |
| 1/14/2026 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | MONDELEZ INTERNATIONALUNITED STA |
| 1/14/2026 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | MONDELEZ INTERNATIONALUNITED STA |
| 12/11/2025 | BAKLAVA 03SFT64 | PAT SAFCANADA |
| 12/10/2025 | ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.) 13FGT02 | |
| 12/10/2025 | ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.) 13FGT02 | |
| 12/2/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 12/2/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 12/2/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 12/2/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 12/2/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 11/24/2025 | FRUIT BEVERAGE BASE, N.E.C. 30AGH99 | PEXVARGT S.A.GUATEMALA |
| 10/28/2025 | CARBONATED SOFT DRINK, N.E.C. 29BHT99 | |
| 10/9/2025 | SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C. 03RGT99 | |
| 10/9/2025 | SWEET GOODS WITHOUT CUSTARD OR CREAM FILLING, N.E.C. 03RGT99 |
Frequently Asked Questions
What is FDA violation code 64?
64 is an FDA violation code that indicates: "The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.". This violation is based on 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 64?
According to FDA Import Refusal data, there have been 1596 import refusals issued for violation code 64, affecting 812 unique firms.
When was the most recent refusal for violation 64?
The most recent import refusal for violation 64 was on January 14, 2026.
What products are commonly refused for violation 64?
Products commonly refused under violation 64 include: CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), BAKLAVA, ICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 64?
Violation code 64 is based on 402(c), 403(m), 801(a)(3); ADULTERATION, MISBRANDING 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.