Retinoid
Where is Isotretinoin made?
16 companies sell it under their own name and 1 repackager rebottle it. Their labels name 8 factories in the United States, India, New Zealand and Switzerland.
United States 3India 3New Zealand 1Switzerland 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn10 mg, 20 mg, 30 mg, 40 mg · NDC 61748-301, 61748-302, 61748-303 +1 | Douglas Manufacturing LimitedMakes it | Lincoln Auckland, New Zealand | Problems found, fixed voluntarilyMay 2025 |
| Swiss Caps AGMakes it | Kirchberg, Switzerland | Problems found, fixed voluntarilyJun 2023 | |
| Caraco Pharmaceutical Laboratories, Ltd. Absorica, Absorica LD8 mg, 10 mg, 16 mg, 20 mg, 24 mg, 25 mg · NDC 57664-020, 10631-115, 10631-003 +15 | Galephar Pharmaceutical Research Inc.Makes it | Humacao, PR, United States | No problems foundJun 2025 |
| Ohm Laboratories Inc.Makes it | New Brunswick, NJ, United States | No problems foundOct 2024 | |
| Amneal Pharmaceuticals10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg · NDC 69238-1174, 69238-1254, 69238-1175 +7 | Amneal Pharmaceuticals of New York, LLCMakes it, tests it, packages it and labels it | Brookhaven, NY, United States | No problems foundSep 2026 |
| Aurobindo Pharma Limited10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg · NDC 59651-631, 59651-632, 84386-009 +6 | Apl Healthcare LimitedMakes it and tests it | Tirupati, India | Problems found, fixed voluntarilyDec 2025 |
| BluePoint Laboratories.10 mg, 20 mg, 30 mg, 40 mg · NDC 68001-652, 68001-653, 68001-654 +1 | Dr. Reddy's Laboratories LimitedMakes it, tests it and packages it | India | Problems found, fixed voluntarilyMay 2023 |
| Cadila Healthcare Limited10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg · NDC 70771-1557, 70771-1662, 70771-1558 +7 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Dr.Reddy's Laboratories Ltd.10 mg, 20 mg, 30 mg, 40 mg · NDC 55111-135, 55111-136, 55111-113 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | India | Problems found, fixed voluntarilyMay 2023 |
| Galephar Pharmaceutical Research Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 66277-336, 66277-337, 66277-335 +3 | Galephar Pharmaceutical Research Inc.Makes it, tests it and packages it | Humacao, PR, United States | No problems foundJun 2025 |
| JG Pharma Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 72143-251, 72143-252, 72143-253 +1 | Dr. Reddy's Laboratories LimitedMakes it and tests it | India | Problems found, fixed voluntarilyMay 2023 |
| Upsher-Smith Laboratories, Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 0245-0570, 0832-8301, 0245-0571 +4 | Douglas Manufacturing LimitedMakes it | Lincoln Auckland, New Zealand | Problems found, fixed voluntarilyMay 2025 |
| Zydus Pharmaceuticals (USA) Inc.10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg · NDC 70710-1022, 70710-1574, 70710-1023 +7 | Zydus Lifesciences LimitedMakes it and tests it | Ahmedabad, India | Problems found, fixed voluntarilyAug 2022 |
| Actavis Pharma, Inc.10 mg, 20 mg, 25 mg, 30 mg, 35 mg, 40 mg · NDC 0591-2433, 0591-2434, 0591-2451 +3 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mayne Pharma Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 68308-570, 68308-781, 68308-571 +5 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Mylan Pharmaceuticals Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 0378-6611, 0378-6612, 0378-6613 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Teva Pharmaceuticals USA, Inc.10 mg, 20 mg, 30 mg, 40 mg · NDC 0555-1054, 0555-1055, 0555-1056 +1 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Upsher-Smith Laboratories, LLC40 mg · NDC 0245-0575 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Isotretinoin 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.
- Physicians Total Care, Inc.:
54868-5039,54868-5041,54868-6378,54868-6307+6
Recalls
- Apr 6, 2026 · Class II · Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin - Feb 24, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications - Jan 12, 2026 · Class II · Teva Pharmaceuticals USA, Inc · 2 recall notices
Superpotent and Subpotent - Mar 28, 2024 · Class II · Teva Pharmaceuticals USA, Inc
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit - Nov 15, 2019 · Class II · Akorn, Inc.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product. - Oct 16, 2019 · Class III · Amneal Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. - Jun 7, 2019 · Class III · Akorn Inc
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly. - Dec 7, 2018 · Class III · Sun Pharmaceutical Industries, Inc.
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. - May 22, 2017 · Class II · Dr. Reddy's Laboratories, Inc. · 4 recall notices
Failed Dissolution Specifications: out of specification results observed for low dissolution. - Feb 15, 2017 · Class III · Dr. Reddy's Laboratories, Inc. · 3 recall notices
Failed dissolution specifications - low dissolution results at S3 stage. - Aug 29, 2016 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications - Jun 26, 2015 · Class II · Ranbaxy Inc.
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.