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
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Classification
Class II
Status
Ongoing
Lot
Lots#: 100067507, 100067508, Exp 07/31/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
Teva Pharmaceuticals USA, Inc — Class II Recall | MedicineWatch US