Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Dr. Reddy's Laboratories Limited | India | Makes it and tests it | Problems found, fixed voluntarilyMay 12, 2023 · 1 inspection |
| Reed-Lane, Inc. | Wayne, NJ, United States | Packages it | No problems foundOct 17, 2025 · 7 inspections |
Recalls
- May 22, 2017 · Class II · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Lots: Lot #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541, KB50542, KB50543, KB50544, KB50545, KB50546, KB50547, KB50548, KB50549, KB50550, KB50551, Exp 07/17; 01KB50643, 01KB50644, KB50640, KB50641, KB50642, KB50645, Exp 08/17; KB50715, K… - Feb 15, 2017 · Class III · Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Lots: Lot # 01KB60250, Exp 3/18
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Isotretinoin: every company that makes it
- Form
- capsule, gelatin coated, oral
- Strength
- 40 mg
- Approval
- ANDA ANDA202099
- On the market since
- Mar 26, 2013
- Package NDCs
55111-137-7955111-137-81- Official label
- DailyMed (National Library of Medicine), updated Sep 20, 2026
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