Corticosteroid
Where is Fluocinonide made?
21 companies sell it under their own name and 14 repackagers rebottle it. Their labels name 12 factories in the United States, India, Canada, Israel and Spain.
United States 5India 4Canada 1Israel 1Spain 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.5 mg per 1 g, 0.5 mg per 1 mL, 1 mg per 1 g · NDC 51672-1386, 51672-1253, 51672-1254 +4 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Taro Pharmaceutical Industries Ltd.Makes it | Haifa Bay, Israel | No problems foundDec 2022 | |
| Lupin Pharmaceuticals, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 43386-095, 43386-026 | Lupin LimitedMakes it, tests it and packages it | Pithampur, India | Problems found, fixed voluntarilyJul 2025 |
| Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 | |
| Cadila Healthcare Limited0.5 mg per 1 mL, 1 mg per 1 g · NDC 70771-1375, 70771-1393 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Cosette Pharmaceuticals, Inc.0.5 mg per 1 g · NDC 0713-0663, 0713-0664 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Encube Ethicals Private Limited0.5 mg per 1 mL · NDC 21922-001 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Encube Ethicals, Inc.0.5 mg per 1 g · NDC 21922-064 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Impax Generics0.5 mg per 1 g · NDC 0115-1705, 0115-1706, 0115-1707 | GW Laboratories, Inc.Makes it | Location not on file | Not inspected on record |
| Macleods Pharmaceuticals Limited0.5 mg per 1 mL · NDC 33342-320 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Northstar Rx LLC.0.5 mg per 1 mL · NDC 72603-703 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Novel Laboratories, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 40032-095, 40032-026 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Quagen Pharmaceuticals LLC0.5 mg per 1 mL · NDC 70752-154 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Saptalis Pharmaceuticals, LLC.0.5 mg per 1 mL · NDC 71656-094 | Saptalis Pharmaceuticals LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Teligent Pharma, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL, 1 mg per 1 g · NDC 52565-040, 52565-029, 52565-054 +2 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Viona Pharmaceuticals Inc.1 mg per 1 g · NDC 72578-087 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Xiromed, LLC.0.05 mg per 1 g · NDC 70700-146 | Laboratorios Liconsa SAUMakes it | Azuqueca De Henares, Spain | Problems found, fixed voluntarilyJan 2025 |
| Zydus Pharmaceuticals (USA) Inc.0.5 mg per 1 mL · NDC 70710-1284 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Amneal Pharmaceuticals0.5 mg per 1 g · NDC 69238-1534 | The label doesn't name the factory. Plants this company names for other drugs | ||
| E. FOUGERA & CO., A division of Nycomed US Inc.0.5 mg per 1 mL · NDC 0168-0134 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd0.5 mg per 1 g · NDC 45802-761 | The label doesn't name the factory. Plants this company names for other drugs | ||
| PureTek Corporation1 mg per 1 g · NDC 59088-755 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.0.5 mg per 1 g · NDC 0093-0263, 0093-0262, 0093-0264 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluocinonide in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-1671,50090-1784,50090-3277,50090-6309+1 - Aidarex Pharmaceuticals LLC:
33261-560 - Asclemed USA, Inc.:
76420-530,76420-509 - Bryant Ranch Prepack:
63629-2338,63629-2339,63629-2337,72162-1972+8 - Central Texas Community Health Centers:
76413-107 - H.J. Harkins Co., Inc.:
52959-652 - MedVantx, Inc.:
66116-512 - NuCare Pharmaceuticals.Inc.:
68071-2667,68071-2808,68071-4219,68071-4921+5 - Physicians Total Care, Inc.:
54868-0431,54868-3023,54868-3435,54868-3408+2 - Preferred Pharmaceuticals, Inc..:
68788-8554,68788-8593 - RPK Pharmaceuticals, Inc.:
53002-9202,53002-9201,53002-9200 - Rebel Distributors Corp..:
21695-207,21695-979 - RedPharm Drug. Inc.:
67296-1407 - Stat Rx USA:
16590-368
Recalls
- Mar 25, 2026 · Class II · Sun Pharmaceutical Industries Inc · 3 recall notices
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - Mar 15, 2022 · Class II · Teligent Pharma, Inc. · 3 recall notices
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Sep 20, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: traces of Dapsone were found in the finished product. - Mar 17, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.