Prescription drug
Where is Ciclopirox made?
17 companies sell it under their own name and 8 repackagers rebottle it. Their labels name 8 factories in the United States, Canada and India.
United States 4Canada 2India 2
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Acella Pharmaceuticals, LLC2.28 g per 1 mL, 80 mg per 1 mL · NDC 42192-714, 42192-715 | Acella Pharmaceuticals, LLCMakes it | Alpharetta, GA, United States | Not inspected on record |
| Groupe PARIMA Inc.Makes it | Montreal, Canada | Problems found, fixed voluntarilyAug 2023 | |
| Akorn71.3 mg per 1 mL · NDC 50383-419 | AkornMakes it | Location not on file | Not inspected on record |
| Caraco Pharmaceutical Laboratories, Ltd.7.7 mg per 1 g, 10 mg per 0.96 mL · NDC 51672-1351, 51672-1318 | Sun Pharma Canada Inc.Makes it | Brampton, Canada | No problems foundMar 2026 |
| Cosette Pharmaceuticals, Inc.7.7 mg per 1 g · NDC 0713-0638 | 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.1 g per 100 mL, 80 mg per 1 mL · NDC 21922-105, 21922-053 | Encube Ethicals LimitedMakes it, tests it, packages it and labels it | Ponda, India | Problems found, fixed voluntarilyJun 2024 |
| Glenmark Pharmaceuticals Inc., USA7.7 mg per 1 g · NDC 68462-455, 68462-297 | Glenmark Pharmaceuticals LimitedMakes it and tests it | Goa, India | Problems found, fixed voluntarilyJun 2026 |
| Leading Pharma, LLC7.7 mg per 1 mL · NDC 69315-309 | Teligent Pharma, Inc.Makes it and packages it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Medimetriks Pharmaceuticals, Inc.2.28 g per 1 mL · NDC 43538-500 | Cosette Pharmaceuticals, Inc.Makes it, tests it, packages it and labels it | South Plainfield, New Jersey, United States | No problems foundNov 2024 |
| Sincerus Florida, LLC3 g per 100 g · NDC 72934-1042 | Sincerus Florida, LLCMakes it | Location not on file | Not inspected on record |
| Taro Pharmaceuticals U.S.A., Inc.80 mg per 1 mL · NDC 51672-5302 | Cosette Pharmaceuticals, Inc.Makes it | South Plainfield, New Jersey, United States | No problems foundNov 2024 |
| Teligent Pharma, Inc.10 mg per 0.96 mL · NDC 52565-032 | Teligent Pharma, Inc.Makes it | Buena, New Jersey, United States | Serious problems, FDA actionAug 2021 |
| Actavis Pharma, Inc.10 mg per .96 mL · NDC 0591-2159 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Chartwell RX, LLC.71.3 mg per 1 mL · NDC 62135-814 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Innocutis Holdings LLC2.28 g per 1 mL · NDC 68712-027 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis Israel Pharmaceuticals Ltd1 g per 100 mL, 7.7 mg per 1 g, 7.7 mg per 1 mL, 80 mg per 1 mL · NDC 45802-401, 45802-138, 45802-400 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Padagis US LLC7.7 mg per 1 g · NDC 0574-2061 | The label doesn't name the factory. Plants this company names for other drugs | ||
| VersaPharm Incorporated80 mg per 1 mL · NDC 61748-200 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Ciclopirox 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:
50090-6562 - Advanced Rx Pharmacy of Tennessee, LLC:
80425-0225 - Bryant Ranch Prepack:
63629-8622,63629-8621,63629-8620,63629-8625+16 - Dispensing Solutions Inc.:
68258-3996 - Physicians Total Care, Inc.:
54868-5270,54868-6064 - Preferred Pharmaceuticals, Inc..:
68788-8755,68788-6797 - RPK Pharmaceuticals, Inc.:
53002-9450 - Rebel Distributors Corp..:
21695-475
Recalls
- Dec 9, 2025 · Class II · Sun Pharma /Taro
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint - Feb 13, 2019 · Class III · Perrigo New York, Inc.
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. - Jan 19, 2018 · Class III · G & W Laboratories, Inc.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration. - Mar 20, 2017 · Class III · G & W Laboratories, Inc.
Labeling: Incorrect or Missing Package Insert: product lots packaged with an out-of-date insert. - Oct 16, 2013 · Class III · Taro Pharmaceuticals U.S.A., Inc.
Subpotent. drug
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.