Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Amneal Pharmaceuticals of New York, LLC | Brookhaven, NY, United States | Makes it, tests it, packages it and labels it | No problems foundSep 25, 2026 · 14 inspections |
Recalls
- Oct 16, 2019 · Class III · Amneal Pharmaceuticals, Inc.
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Lots: Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019
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, liquid filled, oral
- Strength
- 30 mg
- Approval
- ANDA ANDA207792
- On the market since
- Oct 2, 2017
- Package NDCs
69238-1017-169238-1017-3- Official label
- DailyMed (National Library of Medicine), updated Aug 27, 2026
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