D-0399-2026 Class II Ongoing
FDA drug recall D-0399-2026 was initiated by MYLAN PHARMACEUTICALS INC on Feb 24, 2026 and is designated Class II. Reason for recall: Failed Dissolution Specifications The recall status is ongoing. Affected quantity: 34850 blister packs.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 11, 2026
- Initiation Date
- Feb 24, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34850 blister packs
Product description
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
Distribution pattern
Nationwide within the United States
Code information
Lot #: 3116110, 3116130, Exp. Date 07/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0399-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026