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Recall Observatory FDA recall evidence

Drug 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

D-0381-2026

February 18, 2026

Class III

Product summary

Firm
Cipla USA, Inc.
Event
Event 98452
Status
Ongoing
Classification
Class III
Quantity
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Official record key
drug-enforcement:D-0381-2026

Official wording

Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Code information: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.