Cipla recalls nilotinib capsules (150 mg and 200 mg) because they failed appearance checks in stability testing
Samples of these nilotinib capsules failed the description and visual appearance tests at the 6-month long-term stability check, so the capsules did not meet the required specifications.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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…
- Company
- Cipla USA, Inc.
- Hazard
- Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
- Units
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules; 164 cartons
- Where sold
- U.S.A. Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- March 3, 2026
- Recall started
- February 18, 2026
- FDA enforcement report
- March 11, 2026
- Identifiers
- Codes: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
- FDA recall number: D-0381-2026
- Codes: Lot #: 5GJ0223, Exp 04/30/2027
- FDA recall number: D-0382-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 | 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 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.
- Classification
- Class III (Ongoing)
- Distribution
- U.S.A. Nationwide
- Quantity
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules; 164 cartons
Related recalls
Cipla recalls cinacalcet tablets over a impurity above the acceptable daily limit
The tablets contain N-nitroso-cinacalcet, an impurity, at a level above the acceptable daily intake, and the notice lists manufacturing practice deviations as the reason.
Cipla USA, Inc. · 31,824 units
Cipla recalls Lanthanum Carbonate 1000mg chewable tablets because tablets failed a hardness test
The tablets failed a stability check because their hardness was out of specification, meaning they did not meet the required standard for how firm the tablets should be.
Cipla USA, Inc. · 1,180 units
Cipla recalls cinacalcet tablets over a possible impurity above the safe daily limit
The tablets contain N-Nitroso Cinacalcet, an impurity, at a level above the acceptable daily intake limit, and the notice also lists manufacturing practice deviations as a reason for the recall.
Cipla USA, Inc. · 272,624 units