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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 5GJ0223, Exp 04/30/2027
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0382-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Feb 18, 2026
- FDA report date
- Mar 11, 2026
- Quantity
- 164 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla USA, Inc.
Original FDA data
Every field from FDA enforcement report D-0382-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98452
- Address
- 10 Independence Blvd
- Code information
- Lot #: 5GJ0223, Exp 04/30/2027
- Postal code
- 07059-2730
- Report date
- Mar 11, 2026
- Product type
- Drugs
- Recall number
- D-0382-2026
- Classification
- Class III
- Recalling firm
- Cipla USA, Inc.
- Product quantity
- 164 cartons
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Feb 18, 2026
- Initial firm notification
- Letter
- Center classification date
- Mar 3, 2026