FDA Drugs recall ·
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only… recall
- Recall number
- D-0381-2026
- Date
- (initiated February 18, 2026)
- Company / brand
- Cipla USA, Inc.
10 Independence Blvd, Warren, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Distribution
U.S.A. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0381-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.