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Recall Observatory FDA recall evidence

Drug product

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

February 18, 2026

Class III

Product summary

Firm
Cipla USA, Inc.
Event
Event 98452
Status
Ongoing
Classification
Class III
Quantity
164 cartons
Official record key
drug-enforcement:D-0382-2026

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 #: 5GJ0223, 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.