Nilotinib Capsule
FDA Recall NDC 69097-032
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Nilotinib (NDC 69097-032). A significant event, classified as Class III, was initiated on Feb 18, 2026 by Cipla Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Feb 18, 2026
Mar 11, 2026
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Recall Profile & Regulatory Data
Event ID
98452
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
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
Batch or Lot Expiration Information
Lot# : 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Affected Packages Involved in this Recall
69097-030-08Product
69097-030-16Product
69097-030-63Product
69097-031-17Product
69097-031-56Product
69097-031-74Product
69097-031-76Product
69097-031-73Product
69097-031-91Product
69097-032-17Product
69097-032-56Product
69097-032-74Product
69097-032-76Product
69097-032-73Product
69097-032-91Product
Class III Ongoing
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Feb 18, 2026
Mar 11, 2026
164 cartons
Recall Profile & Regulatory Data
Event ID
98452
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
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
Batch or Lot Expiration Information
Lot# : 5GJ0223, Exp 04/30/2027
Affected Packages Involved in this Recall
69097-030-08Product
69097-030-16Product
69097-030-63Product
69097-031-17Product
69097-031-56Product
69097-031-74Product
69097-031-76Product
69097-031-73Product
69097-031-91Product
69097-032-17Product
69097-032-56Product
69097-032-74Product
69097-032-76Product
69097-032-73Product
69097-032-91Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
