Cipla USA, Inc. recalls Nilotinib Capsules
- Recalling company
- Cipla USA, Inc.
- 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
- Reason
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Feb 18, 2026
- Reported
- Mar 11, 2026
- Distribution
- U.S.A. Nationwide
- Status
- Ongoing
- Quantity
- 164 cartons
- Lot / codes
- Lot #: 5GJ0223, Exp 04/30/2027
- Company location
- Warren, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0382-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0382-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.