Claravis (isotretinoin capsule, USP) 10 mg
Teva is recalling Claravis 10 mg capsules (NDC 0555-1054-56, 0555-1054-86) due to out-of-specification Tretinoin impurity levels.
Do not use this medication. Contact your pharmacy or healthcare provider immediately for a replacement or alternative treatment. Return the recalled product to your pharmacy.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
How to identify it
UPC 100067507 100067508
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.
Where it was sold
Distributed in US.
Official source
Other recent recalls from Teva Pharmaceuticals USA, Inc
Editorial summary by Recall Canary · last updated 2026-05-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification