Corticosteroid
Where is Clobetasol made?
35 companies sell it under their own name and 11 repackagers rebottle it. Their labels name 26 factories in India, the United States, Canada, Israel and Taiwan.
India 11United States 8Canada 4Israel 2Taiwan 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Northstar Rx LLC.0.05 g per 100 mL, 0.5 mg per 1 g · NDC 16714-030, 16714-782, 72603-323 +1 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Glenmark Pharmaceuticals LimitedMakes it and tests it | Solan, India | Serious problems, FDA actionJun 2022 | |
| Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 | |
| Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 | |
| Alembic Pharmaceuticals Inc.0.05 g per 1 mL, 0.05 g per 100 mL, 0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 62332-425, 62332-548, 62332-707 +3 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| Contract Pharmaceuticals Limited CanadaMakes it | Mississauga, Canada | Problems found, fixed voluntarilyNov 2023 | |
| Amneal Pharmaceuticals0.05 g per 100 mL, 0.5 mg per 1 g · NDC 69238-1732, 69238-1532 | Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 |
| Amneal Pharmaceuticals, LLCMakes it, tests it, packages it and labels it | Piscataway, NJ, United States | No problems foundApr 2026 | |
| Caraco Pharmaceutical Laboratories, Ltd.0.05 g per 1 mL, 0.05 g per 100 mL, 0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 51672-1371, 51672-1347, 51672-1297 +6 | 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 | |
| Encube Ethicals, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 21922-017, 21922-016, 21922-061 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Indore, India | Not inspected on record | |
| Lupin Pharmaceuticals, Inc.0.05 g per 100 mL, 0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 68180-536, 43386-096, 68180-956 +1 | 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 | |
| Primus Pharmaceuticals, Inc. Impoyz0.25 mg per 1 g · NDC 68040-713 | DPT Laboratories, Ltd.Makes it and packages it | San Antonio, TX, United States | No problems foundMay 2024 |
| Symbiotec Pharmalab LimitedMakes the active ingredient | Indore, India | Problems found, fixed voluntarilyApr 2026 | |
| Akorn.05 g per 100 mL, 0.4625 mg per 1 mL, .5 mg per 1 mL, 0.5 mg per 1 g · NDC 50383-978, 50383-979, 50383-266 +3 | AkornMakes it | Location not on file | Not inspected on record |
| Alembic Pharmaceuticals Limited0.05 g per 1 mL, 0.05 g per 100 mL, 0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 46708-425, 46708-548, 46708-465 +3 | Alembic Pharmaceuticals LimitedMakes it and tests it | Vadodara, India | No problems foundMar 2023 |
| Aurobindo Pharma Limited0.5 mg per 1 g · NDC 59651-732 | Apl Healthcare LimitedMakes it and tests it | Mahabubnagar, India | No problems foundJan 2023 |
| Bora Pharmaceuticals Ophthalmic Inc. Taoyuan plant Clobetasol Propionate0.5 mg per 1 mL · NDC 81772-007 | Bora Pharmaceutical Laboratories Inc. Taoyuan PlantMakes it and packages it | Taoyuan, Taiwan | Problems found, fixed voluntarilyJul 2026 |
| Cadila Healthcare Limited0.05 g per 1 mL, 0.05 g per 100 mL, 0.5 mg per 1 g · NDC 70771-1080, 70771-1498, 70771-1209 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Cosette Pharmaceuticals, Inc.0.5 mg per 1 g · NDC 0713-0656 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Glenmark Pharmaceuticals Inc., USA0.5 mg per 1 g · NDC 68462-608, 68462-625 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Chhatrapati Sambhajinagar (previously known as Aurangabad), India | No problems foundSep 2024 |
| Golden State Medical Supply, Inc.0.5 mg per 1 mL · NDC 51407-737 | Saptalis Pharmaceuticals, LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| HyGen Pharmaceuticals, Inc.0.4625 mg per 1 mL · NDC 70030-166 | Hi-Tech Pharmacal Co., Inc.Makes it | Location not on file | Not inspected on record |
| Macleods Pharmaceuticals Limited0.4625 mg per 1 mL, 0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 33342-321, 33342-506, 33342-326 | Oxalis LabsMakes it, tests it, packages it and labels it | Solan, India | Problems found, fixed voluntarilyJun 2023 |
| Mayne Pharma Inc.0.05 g per 100 mL · NDC 68308-664 | G Production IncMakes it | Baie D'Urfe, Canada | No problems foundFeb 2023 |
| Medimetriks Pharmaceuticals, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 43538-952, 43538-950 | Padagis Israel Pharmaceuticals LtdMakes it | Yeruham, Israel | No problems foundOct 2022 |
| Micro Labs Limited0.5 mg per 1 mL · NDC 42571-362 | Saptalis Pharmaceuticals, LLCMakes it | Hauppauge, NY, United States | Problems found, fixed voluntarilyMar 2026 |
| Novel Laboratories, Inc.0.5 mg per 1 g, 0.5 mg per 1 mL · NDC 40032-096, 40032-028 | Novel Laboratories, Inc.Makes it and tests it | Somerset, NJ, United States | Problems found, fixed voluntarilyApr 2026 |
| Quagen Pharmaceuticals LLC0.5 mg per 1 mL · NDC 70752-153 | Quagen Pharmaceuticals LLCMakes it and packages it | West Caldwell, NJ, United States | No problems foundApr 2026 |
| Teligent Pharma, Inc..05 mg per 100 mL, 0.5 mg per 1 g · NDC 52565-055, 52565-094, 52565-051 +2 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| The J. Molner Company LLC0.5 mg per 1 g · NDC 83148-064 | Groupe PARIMA Inc.Makes it, packages it and labels it | Montreal, Canada | Problems found, fixed voluntarilyAug 2023 |
| Torrent Pharma, Inc.0.5 mg per 1 g · NDC 13668-569 | Torrent Pharmaceuticals LimitedMakes it, tests it and packages it | Pithampur, India | Problems found, fixed voluntarilyOct 2019 |
| Viona Pharmaceuticals Inc.0.05 g per 100 mL · NDC 72578-085 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Zydus Pharmaceuticals (USA) Inc.0.05 g per 1 mL, 0.5 mg per 1 g · NDC 68382-998, 70710-1401 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | No problems foundFeb 2025 |
| Actavis Pharma, Inc.0.05 g per 100 mL · NDC 0472-0404, 0472-0403 | The label doesn't name the factory. Plants this company names for other drugs | ||
| AvKARE, Inc.0.5 mg per 1 g · NDC 42291-077, 42291-076 | 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 0168-0269 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Eyenovia, Inc. Clobetasol Propionate0.5 mg per 1 mL · NDC 81046-0319 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Harrow Eye, LLC Byqlovi0.5 mg per 1 mL · NDC 82667-021 | The label doesn't name the factory. Plants this company names for other drugs | ||
| INA Pharmaceutics Inc.0.25 mg per 1 g · NDC 74157-710 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd0.05 g per 100 mL, 0.5 mg per 1 g · NDC 45802-961, 45802-437, 45802-925 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Xiromed, LLC.0.5 mg per 1 g · NDC 70700-109, 70700-106 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Clobetasol 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:
50090-4630,50090-5778,50090-4146,50090-2405+16 - Bryant Ranch Prepack:
63629-9461,72162-1442,63629-8638,63629-8637+20 - Direct Rx:
61919-329,72189-262 - NuCare Pharmaceuticals.Inc.:
68071-1596,68071-2671,68071-2764,68071-3922 - Physicians Total Care, Inc.:
54868-5657,54868-5292,54868-5510,54868-3698+4 - Preferred Pharmaceuticals, Inc..:
68788-4001,68788-7963 - Proficient Rx LP:
82804-083,82804-133 - RPK Pharmaceuticals, Inc.:
53002-9970 - Rebel Distributors Corp..:
21695-483,21695-201,42254-153,42254-174+1 - Remedyrepack Inc.:
70518-4374 - Unit Dose Services:
50436-9985
Recalls
- Aug 3, 2026 · Class II · Lupin Pharmaceuticals Inc.
Failed content uniformity specifications. - Jan 20, 2023 · Class III · Lupin Pharmaceuticals Inc.
Subpotent Drug: Low assay result observed during long-term stability testing. - Mar 15, 2022 · Class II · Teligent Pharma, Inc. · 5 recall notices
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. - Dec 15, 2021 · Class I · Taro Pharmaceuticals U.S.A., Inc.
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria - Nov 5, 2020 · Class III · Teligent Pharma, Inc.
Superpotent and Subpotent; low and high assay results - Nov 15, 2019 · Class III · Glenmark Pharmaceuticals Inc., USA · 2 recall notices
Defective delivery system; product is not foaming or is coming out as liquid. - Jan 11, 2019 · Class III · Oxalis Labs
Defective Container; complaints of leakage. - Dec 21, 2017 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications - Jun 2, 2017 · Class III · G & W Laboratories, Inc.
Failed impurities/degradation specifications: This product is being recalled due to out of specification results for Clobetasol Related Compound A, a known impurity which is a degradation product. - Jul 25, 2013 · Class III · Hi-Tech Pharmacal Co., Inc.
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.