Corticosteroid
Where is Fluocinolone Acetonide made?
17 companies sell it under their own name and 4 repackagers rebottle it. Their labels name 9 factories in the United States, Canada and India.
United States 7Canada 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.0.1 mg per 1 mL, 0.11 mg per 118.28 mL · NDC 51672-1365, 51672-1356, 51672-1357 | Sun Pharma Canada Inc.Makes it and tests it | Brampton, Canada | No problems foundMar 2026 |
| Cosette Pharmaceuticals, Inc.0.1 mg per 1 g, 0.25 mg per 1 g · NDC 0713-0223, 0713-0709, 0713-0222 +1 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Encube Ethicals, Inc.0.1 mg per 1 mL · NDC 21922-003 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Lupin Pharmaceuticals, Inc.0.1 mg per 1 mL · NDC 43386-069 | Novel Laboratories, Inc.Makes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Medimetriks Pharmaceuticals, Inc. Synalar0.25 mg per 1 g · NDC 43538-910, 43538-900 | Ferndale Laboratories, Inc.Makes it, tests it, packages it and labels it | Ferndale, MI, United States | Problems found, fixed voluntarilyFeb 2026 |
| Quagen Pharmaceuticals LLC0.11 mg per 1 mL · NDC 70752-159, 70752-156, 70752-158 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Rising Pharma Holdings, Inc.0.11 mg per 1 mL · NDC 64980-329, 64980-330, 64980-331 | Lyne Laboratories, Inc.Makes it, tests it, packages it and labels it | Brockton, MA, United States | Problems found, fixed voluntarilyMar 2026 |
| Royal Pharmaceuticals Dermotic, Derma-Smoothe/Fs, Derma-Smoothe/FS0.11 mg per 1 mL · NDC 68791-103, 68791-102, 68791-101 | Hill Dermaceuticals, Inc.Makes it | Sanford, FL, United States | Problems found, fixed voluntarilyOct 2025 |
| Teligent Pharma, Inc.0.1 mg per 1 g, 0.1 mg per 1 mL, 0.25 mg per 1 g · NDC 52565-031, 52565-012, 52565-020 +1 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| ANI Pharmaceuticals, Inc. Yutiq, Iluvien.1 mg per 1 g, 0.18 mg, 0.19 mg, .25 mg per 1 g, 0.25 mg per 1 g · NDC 62559-288, 62559-289, 68611-180 +2 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Actavis Pharma, Inc.0.1 mg per 1 mL · NDC 0591-2990 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Amneal Pharmaceuticals LLC0.11 mg/118.28mL · NDC 65162-703 | The label doesn't name the factory. Plants this company names for other drugs | ||
| E. FOUGERA & CO., A division of Nycomed US Inc.0.1 mg per 1 mL, 0.25 mg per 1 g · NDC 0168-0059, 0168-0064 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.0.1 mg per 1 mL · NDC 10135-670 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd0.01 mg per 100 mL, 0.11 mg per 1 mL · NDC 45802-485, 45802-887, 45802-009 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Patrin Pharma, Inc.0.11 mg per 1 mL · NDC 39328-079 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Solutech Pharmaceuticals LLC0.1 mg per 1 mL · NDC 70350-5218 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Fluocinolone Acetonide 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:
50090-7958,50090-6780 - Bryant Ranch Prepack:
72162-1412,63629-8656,63629-8655,72162-1434+8 - Physicians Total Care, Inc.:
54868-2264,54868-5351,54868-6347,54868-6383 - Stat Rx USA:
16590-097
Recalls
- Dec 30, 2025 · Class III · Sun Pharmaceutical Industries Inc
Failed Impurities/Degradation Specifications: Out of specification result was obtained for the known impurity D. - Nov 4, 2021 · Class II · Amneal Pharmaceuticals of New York, LLC
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. - May 21, 2021 · Class II · Hill Dermaceuticals, Inc.
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. - Jan 15, 2019 · Class II · Lupin Somerset
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical i… - Oct 5, 2018 · Class II · Lupin Somerset
Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis - Jul 5, 2018 · Class II · Teva Pharmaceuticals USA
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants. - Apr 13, 2018 · Class II · Lyne Laboratories, Inc. · 3 recall notices
Subpotent Drug - Feb 22, 2017 · Class III · Novel Laboratories, Inc.
Chemical Contamination - Jan 31, 2014 · Class III · Hill Dermaceuticals, Inc. · 3 recall notices
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing. - Sep 30, 2013 · Class III · G & W Laboratories Inc
Failed Content Uniformity Specifications; at the 18 month time point.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.