Product: 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
Recall initiated: 20260406
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated