CLASS III ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report

Nilotinib Capsules recalled by Cipla USA

Cipla USA is recalling Nilotinib Capsules, distributed nationwide in the US. The recall was initiated on 18 Feb 2026 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027

Quantity recalled271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0381-2026
FDA event ID: 98452
Recalling firm: Cipla USA, Warren, NJ
Classification: Class III
Status: Ongoing
Recall initiated: 18 Feb 2026
FDA classified: 3 Mar 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

18 Feb 2026	Recall initiated by company
3 Mar 2026	Classified by FDA	+13 days
11 Mar 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

U.S.A. Nationwide

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

U.S.A. Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 10 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 98452

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026	CLASS III	Nilotinib Capsules recalled by Cipla USA	Cipla USA	Potency & Assay	Nationwide

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Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Drug	CLASS III	Nilotinib Capsules recalled by Cipla USA	Cipla USA	Potency & Assay	Nationwide