Official recall notice
FDA DrugClass IIINotable
FDA Recall: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, I
- Recall date
- 2026-03-11
- Brand
- Cipla USA, Inc.
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recommended action
What to do
164 cartons
Product description
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.