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 #: KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79… - Feb 15, 2017 · Class III · Dr. Reddy's Laboratories, Inc.
Failed dissolution specifications - low dissolution results at S3 stage.
Lots: Lot # KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18 - Aug 29, 2016 · Class III · Dr. Reddy's Laboratories, Inc.
Failed Dissolution Specifications
Lots: Lot # 79KB60205; Exp. 02/18
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
- 20 mg
- Approval
- ANDA ANDA202099
- On the market since
- Mar 26, 2013
- Package NDCs
55111-136-7955111-136-81- Official label
- DailyMed (National Library of Medicine), updated Sep 20, 2026
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