Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister pack…

Recall date

April 6, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0521-2026

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA, Inc

Sold / distributed

Nationwide in the USA, Puerto Rico and Virgin Islands

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.