FDAFDA · Food and drugs·Recall number D-0381-2026
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
Published March 11, 2026 · Recall initiated: February 18, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NILOTINIB
- Manufacturer
- Cipla USA, Inc.
- Distributor
- U.S.A. Nationwide
- Lot
- Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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