Official recall notice
FDA DrugClass IINotable
FDA Recall: Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured
- Recall date
- 2026-03-11
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Failed Dissolution Specifications
Recommended action
What to do
34850 blister packs
Product description
Failed Dissolution Specifications