Corticosteroid, Vitamin D Analog
Where is Betamethasone and Calcipotriene made?
7 companies sell it under their own name and 2 repackagers rebottle it. Their labels name 3 factories in Canada, the United States and Ireland.
Canada 1United States 1Ireland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Caraco Pharmaceutical Laboratories, Ltd.50 mg per 1 g / 50 ug per 1 g · NDC 51672-1402 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Cosette Pharmaceuticals, Inc.50 ug per 1 g / 0.5 mg per 1 g · NDC 0713-0848 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| LEO Pharma Inc. Taclonex, Enstilar50 ug per 1 g / 0.5 mg per 1 g · NDC 50222-501, 50222-302 | LEO Laboratories Ltd.Makes it, tests it, packages it and labels it | Dublin, Ireland | Problems found, fixed voluntarilyJan 2026 |
| Perfero Pharma, Inc.0.5 mg per 1 g / 0.05 mg per 1 g · NDC 87143-100 | Cosette Pharmaceuticals NC Laboratories, LLCMakes it, tests it, packages it and labels it | Lincolnton, NC, United States | Problems found, fixed voluntarilyJul 2023 |
| Prasco Laboratories50 ug per 1 g / 0.5 mg per 1 g · NDC 66993-938 | LEO Laboratories Ltd.Makes it, tests it, packages it and labels it | Dublin, Ireland | Problems found, fixed voluntarilyJan 2026 |
| MC2 Therapeutics Ltd Wynzora50 ug per 1 g / 64 mg per 1 g · NDC 73499-001 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd50 ug per 1 g / .643 mg per 1 g · NDC 45802-816 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Betamethasone and Calcipotriene 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.
- Bryant Ranch Prepack:
63629-2520,72162-1428,63629-8617 - Physicians Total Care, Inc.:
54868-5680,54868-6091
Recalls
- Jan 16, 2017 · Class III · Leo Pharma Inc
Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.