Official recall notice
FDA DrugClass IINotable
FDA Recall: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with
- Recall date
- 2026-04-29
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Recommended action
What to do
5,101 cartons
Product description
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin