D-0521-2026 Class II Ongoing
FDA drug recall D-0521-2026 was initiated by Teva Pharmaceuticals USA, Inc on Apr 6, 2026 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin The recall status is ongoing. Affected quantity: 5,101 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 29, 2026
- Initiation Date
- Apr 6, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,101 cartons
Product Description
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Distribution Pattern
Nationwide in the USA, Puerto Rico and Virgin Islands
Code Information
Lots#: 100067507, 100067508, Exp 07/31/2026
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0521-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026