Melanin Synthesis Inhibitor
Where is Hydroquinone made?
18 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 6 factories in the United States.
United States 6
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Omp, Inc.40 mg per 1 g, 40 mg per 1 mL · NDC 62032-117, 62032-115, 62032-120 +5 | G.s. Cosmeceutical Usa, Inc.Makes it | Livermore, CA, United States | Problems found, fixed voluntarilyAug 2019 |
| Harmony Labs, Inc.Makes it, tests it, packages it and labels it | Location not on file | Not inspected on record | |
| PureTek CorporationMakes it, packages it and labels it | San Fernando, CA, United States | Problems found, fixed voluntarilyMar 2025 | |
| Acella Pharmaceuticals, LLC40 mg per 1 g · NDC 42192-151 | Acella Pharmaceuticals, LLCMakes it | Alpharetta, GA, United States | Not inspected on record |
| Apnar Pharma LP40 mg per 1 g · NDC 24689-101 | Invaderm CorporationMakes it, tests it and packages it | Somerset, NJ, United States | Problems found, fixed voluntarilyJun 2023 |
| Axia Medical Solutions, LLC40 mg per 1 g · NDC 68723-143, 68723-142 | Axia Medical Solutions, LLCMakes it | Location not on file | Not inspected on record |
| Dermavance Pharmaceuticals40 mg per 1 g · NDC 30815-0040 | Medical Products Laboratories, Inc.Makes it | Philadelphia, PA, United States | Problems found, fixed voluntarilyJul 2023 |
| PhotoMedex, Inc.40 mg per 1 g · NDC 62362-012 | PhotoMedex, Inc.Makes it | Horsham, Pennsylvania, United States | Problems found, fixed voluntarilyMay 2014 |
| Sincerus Florida, LLC4 g per 100 g, 6 g per 100 g, 8 g per 100 g · NDC 72934-6114, 72934-6223, 72934-6118 +6 | Sincerus Florida, LLCMakes it | Location not on file | Not inspected on record |
| Vi Medical Products Inc.4 g per 100 mL · NDC 70484-101 | Micro Connection Enterprises IncMakes it | Location not on file | Not inspected on record |
| Akron Pharma Inc.40 mg per 1 g · NDC 71399-0400 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Bi-Coastal Pharma International LLC40 mg per 1 g · NDC 42582-700 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Marlex Pharmaceuticals, Inc.40 mg per 1 g · NDC 10135-724 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Nivagen Pharmaceuticals, Inc.40 mg per 1 g · NDC 75834-137 | The label doesn't name the factory. Plants this company names for other drugs | ||
| O Skin Care LLC0.02 g per 1 g · NDC 71421-801 | The label doesn't name the factory. Plants this company names for other drugs | ||
| SOHM, Inc.40 mg per 1 g · NDC 50405-800 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Syntenza Pharmaceuticals LLC40 mg per 1 g · NDC 72056-060 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Westminster Pharmaceuticals, LLC40 mg per 1 g · NDC 69367-174 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Ys Plus Corporation40 mg per 1 mL · NDC 69269-106 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ZO Skin Health, Inc.0.04 g per 1 mL, 0.04 mg per 1 mL, 40 mg per 1 mL, 40 mg per 1 mL / 0.04 g per 1 mL · NDC 42851-036, 42851-035, 42851-037 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Hydroquinone 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:
72162-2422 - Medsource Pharmaceuticals:
45865-214 - NuCare Pharmaceuticals.Inc.:
68071-2748
Recalls
- Sep 23, 2021 · Class II · Monarch PCM, LLC
Finished product specification did not meet USP specifications. - Sep 1, 2021 · Class III · Monarch PCM, LLC
Subpotency: one product for active ingredient assay and another one for preservative assay - Oct 17, 2014 · Class II · Obagi Medical Products
Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.