FDA Recall D-0399-2026
MYLAN PHARMACEUTICALS INC · Morgantown, WV
Class II Ongoing 79 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Reason for recall
Failed Dissolution Specifications
Recall record
- Recall number
D-0399-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide within the United States
- Recall initiated
- 2026-02-24
- Classified by FDA Center
- 2026-03-19
- FDA published
- 2026-03-11
- Recalling firm
- MYLAN PHARMACEUTICALS INC
- Firm location
- Morgantown, WV
Drug identification
- Brand name(s)
- AMNESTEEM
- Generic name(s)
- ISOTRETINOIN
- Manufacturer(s)
- Mylan Pharmaceuticals Inc.
- NDC(s)
0378-6611, 0378-6612, 0378-6613, 0378-6614- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.