Drug recall D-0381-2026
Product
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, 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 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Reason for recall
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Lots and codes
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Recall details
- Recalling firm
- Cipla USA, Inc., Warren, NJ
- Quantity
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 18, 2026
Related products
- Nilotinib – drug information
- NDC 69097-030 Nilotinib · Nilotinib 50 mg/1 · Cipla USA Inc.
- NDC 69097-032 Nilotinib · Nilotinib 200 mg/1 · Cipla USA Inc.
- NDC 69097-031 Nilotinib · Nilotinib 150 mg/1 · Cipla USA Inc.