Violation Code: 82
FDA Violation
Charge Code: RX LEGEND
Violation Details
- Violation Code (ASC ID)
- 82
- Charge Code
- RX LEGEND
- Description
- The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).
- Legal Section
- 502(a) & (f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Galafarm | Kyiv, UKRAINE | 15 |
| 2 | Homeolab USA Inc. | Montreal, CANADA | 9 |
| 3 | Fuzhou Difeng Bio-Tech Co., Ltd. | Fuzhou, CHINA | 6 |
| 4 | Dr Triguna | New Delhi, INDIA | 5 |
| 5 | Tulsi Exports | New Delhi, INDIA | 5 |
| 6 | Origin Biomedicinals Inc. | Halifax, CANADA | 4 |
| 7 | CAPITAINE NAT | Pia, FRANCE | 4 |
| 8 | Jabones Pardo S.A. | Fuenlabrada, SPAIN | 4 |
| 9 | HERBS FOREVER | Amritsar, INDIA | 4 |
| 10 | Leejiham Cosmetics | Seoul, SOUTH KORE | 3 |
| 11 | DREAM COSMETICS | Abigian, IVORY COAS | 3 |
| 12 | Beltapharm SPA | Cusano Milanino, ITALY | 3 |
| 13 | Mylan Pharmaceuticals ULC | Etobicoke, CANADA | 3 |
| 14 | The 0 Company | Tilburg, NETHERLAND | 2 |
| 15 | Elliot Irving Ltd. | Glasgow, UNITED KIN | 2 |
| 16 | Choice Laboratories Limited | Ahmadabad, INDIA | 2 |
| 17 | Allergan Pharmaceuticals Ireland | Westport, IRELAND | 2 |
| 18 | Mektec Corporation | Kaohsiung, TAIWAN | 2 |
| 19 | Matrix Laboratories Ltd | Secunderabad, INDIA | 2 |
| 20 | Splash Corporation | Valenzuela City, PHILIPPINE | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/1/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDL99 | BIOHEAL OTTAWACANADA |
| 7/16/2025 | LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) 62KCA08 | MedopharmINDIA |
| 7/16/2025 | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) 62GDA18 | |
| 7/16/2025 | AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) 56BCE07 | |
| 7/16/2025 | LEVONORGESTREL (ESTROGEN) 64GDY29 | Bayer AGGERMANY |
| 7/16/2025 | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) 62GCA18 | Ronak Exim Pvt. Ltd.INDIA |
| 12/1/2023 | ZINC OXIDE PASTE WITH SALICYLIC ACID (PROTECTANT) 65LBO15 | Balkanpharma-Troyan ADBULGARIA |
| 2/13/2023 | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) 16AMY33 | CAPITAINE NATFRANCE |
| 2/13/2023 | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) 16AMY33 | CAPITAINE NATFRANCE |
| 2/13/2023 | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) 16AMY33 | CAPITAINE NATFRANCE |
| 2/13/2023 | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) 16AEY33 | CAPITAINE NATFRANCE |
| 11/2/2022 | DAILY WEAR SOFT CONTACT LENS TO REDUCE THE PROGRESSION OF MYOPIA 86QIT | Cooper VisionUNITED KIN |
| 10/17/2022 | BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) 64LMJ06 | |
| 9/8/2022 | CLOBETASOL PROPIONATE (GLUCOCORTICOID) 64LCL67 | ZIM TUCKSHOPZIMBABWE |
| 9/30/2021 | ANTI-DIABETIC N.E.C. 61PCP99 | Novo Nordisk A/SDENMARK |
Related Violations
Other violations under the same legal section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 82?
82 is an FDA violation code that indicates: "The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).". This violation is based on 502(a) & (f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 82?
According to FDA Import Refusal data, there have been 188 import refusals issued for violation code 82, affecting 121 unique firms.
When was the most recent refusal for violation 82?
The most recent import refusal for violation 82 was on December 1, 2025.
What products are commonly refused for violation 82?
Products commonly refused under violation 82 include: MISCELLANEOUS PATENT MEDICINES, ETC., LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL), DICLOFENAC SODIUM (ANTI-INFLAMMATORY), AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED), LEVONORGESTREL (ESTROGEN). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 82?
Violation code 82 is based on 502(a) & (f)(1), 801(a)(3); 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.