Recalls / Class III
Class IIID-0382-2026
Product
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each), NDC 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
- Brand name
- Nilotinib
- Generic name
- Nilotinib
- Active ingredient
- Nilotinib
- Route
- Oral
- NDCs
- 69097-030, 69097-031, 69097-032
- FDA application
- NDA218922
- Affected lot / code info
- Lot #: 5GJ0223, Exp 04/30/2027
Why it was recalled
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recalling firm
- Firm
- Cipla USA, Inc.
- Manufacturer
- Cipla USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Independence Blvd, N/A, Warren, New Jersey 07059-2730
Distribution
- Quantity
- 164 cartons
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2026-02-18
- FDA classified
- 2026-03-03
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0382-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.