Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs
Recalled April 29, 2026 · FDA recall D-0521-2026 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin · FDA Class II
Units
5,101 cartons
Sold at
Nationwide in the USA, Puerto Rico and Virgin Islands
Description
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
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.
Manufacturer(s)
Teva Pharmaceuticals USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →