D-0381-2026 Class III Ongoing
FDA drug recall D-0381-2026 was initiated by Cipla USA, Inc. on Feb 18, 2026 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 11, 2026
- Initiation Date
- Feb 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Product Description
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0381-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026