FDAHealthFebruary 18, 2026
Cipla USA, Inc. — 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, Su
⚠️ Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 18, 2026
U.S.A. Nationwide
What's affected?
- 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
- Brand
- NILOTINIB
- Lot code
- 5GJ0220
Additional details
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules.
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