Nilotinib Capsules recall
FDA recall D-0382-2026 · initiated Feb 18, 2026
Cipla USA, Inc. recalled Nilotinib Capsules in Feb 2026 — an FDA Class III recall (D-0382-2026) because Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 164 cartons
Details
- 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
- Recalling company
- Cipla Limited
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S.A. Nationwide
- Initiated
- Feb 18, 2026
- FDA report date
- Mar 11, 2026
Frequently asked
- Was Nilotinib Capsules recalled?
- Cipla USA, Inc. recalled Nilotinib Capsules in Feb 2026 — an FDA Class III recall (D-0382-2026) because Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Nilotinib Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0382-2026 was: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Is a recalled Nilotinib Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Nilotinib Capsules are affected?
- Distributed: U.S.A. Nationwide. The recall covers these lots — Lot #: 5GJ0223, Exp 04/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0382-2026.