Recalls / Class II
Class IID-0399-2026
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.
- Brand name
- Amnesteem
- Generic name
- Isotretinoin
- Active ingredient
- Isotretinoin
- Route
- Oral
- NDCs
- 0378-6611, 0378-6612, 0378-6613, 0378-6614
- FDA application
- ANDA075945
- Affected lot / code info
- Lot #: 3116110, 3116130, Exp. Date 07/2026
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- MYLAN PHARMACEUTICALS INC
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1311 Pineview Dr, N/A, Morgantown, West Virginia 26505-3276
Distribution
- Quantity
- 34850 blister packs
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2026-02-24
- FDA classified
- 2026-03-19
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0399-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.