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
Teva Pharmaceuticals USA, Inc. is recalling Claravis (isotretinoin capsule, USP) 10 mg in 100-count cartons (NDC 0555-1054-56) and 30-count cartons (NDC 0555-1054-86) distributed nationwide and in the Virgin Islands due to out-of-specification levels of the impurity Tretinoin. Affected blister packs are NDC 0555-1054-60.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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.UPC: 100067507, 100067508
| Recall # |
|---|
| N/A |
| D-0521-2026 |
Where it was sold
Distributed nationwide.
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