FDA Recall D-0381-2026

Cipla USA, Inc. · Warren, NJ

Class III Ongoing 85 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

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

Quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

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.

Recall record

Recall number: D-0381-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S.A. Nationwide
Recall initiated: 2026-02-18
Classified by FDA Center: 2026-03-03
FDA published: 2026-03-11
Recalling firm: Cipla USA, Inc.
Firm location: Warren, NJ

Drug identification

Brand name(s): NILOTINIB
Generic name(s): NILOTINIB
Manufacturer(s): Cipla USA Inc.
NDC(s): 69097-030, 69097-031, 69097-032
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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