Cipla: Multiple Packaged In Cartons Capsules
Cipla recalls Nilotinib Capsules (150 mg, 200 mg) over failed stability tests for appearance.
Check your prescription bottles for Nilotinib Capsules. If you have the affected product, contact your pharmacist or Cipla USA for return and replacement instructions.
Why it was recalled
Cipla USA is recalling Nilotinib Capsules in 150 mg and 200 mg strengths due to failed tablet/capsule specifications. Out-of-specification results were observed at the 6-month long-term stability condition for the Description test and Appearance by Visual Inspection test.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | Recall # |
|---|---|
| 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 | D-0381-2026 |
| 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 | D-0382-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Cipla USA, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification