Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Galephar Pharmaceutical Research Inc. | Humacao, PR, United States | Makes it | No problems foundJun 5, 2025 · 6 inspections |
Recalls
- 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.
Lots: Lot: 17F28AA, Exp 1/2020 - Jun 26, 2015 · Class II · Ranbaxy Inc.
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Lots: Lot #:14H04AA, Expiry: 02/28/2017.
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, oral
- Strength
- 10 mg
- Approval
- NDA NDA021951
- On the market since
- Jun 8, 2012
- Package NDCs
10631-115-3110631-115-69- Official label
- DailyMed (National Library of Medicine), updated Aug 19, 2026
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