FDAHealthFebruary 18, 2026
Cipla USA, Inc. — 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 cap
⚠️ 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, 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
- NILOTINIB
- Lot code
- 5GJ0223
Additional details
Lot #: 5GJ0223, Exp 04/30/2027
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 164 cartons.
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