Where it's made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Mylan Pharmaceuticals Inc. names for other drugs.
Recalls
- Feb 24, 2026 · Class II · Mylan Pharmaceuticals Inc
Failed Dissolution Specifications
Lots: Lot #: 3116110, 3116130, Exp. Date 07/2026
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
- ANDA ANDA075945
- On the market since
- Nov 11, 2002
- Package NDCs
0378-6611-850378-6611-93- Official label
- DailyMed (National Library of Medicine), updated Aug 15, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?