MYLAN PHARMACEUTICALS INC recalls Amnesteem
- Recalling company
- MYLAN PHARMACEUTICALS INC
- 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
- Failed Dissolution Specifications
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 24, 2026
- Reported
- Mar 11, 2026
- Distribution
- Nationwide within the United States
- Status
- Ongoing
- Quantity
- 34850 blister packs
- Lot / codes
- Lot #: 3116110, 3116130, Exp. Date 07/2026
- Company location
- Morgantown, WV
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0399-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0399-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.