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Low risk Drugs & MedicationsClass III

Cipla Nilotinib 150 mg Capsules Recall

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipl

Updated February 18, 2026

Cipla USA is recalling Nilotinib 150 mg capsules due to failed stability tests showing changes in appearance and description during long-term storage. The affected batches may not meet required quality standards.

Is the Cipla USA, Inc. recalled? Yes. This product was recalled by FDA on February 18, 2026. Details below.

What is recalled

Nilotinib Capsules, 150 mg per capsule, manufactured by Cipla Ltd. in Verna, Goa, India for Cipla USA, Inc. Affected NDC codes: 69097-031-74 (112-capsule carton), 69097-031-56 (28-capsule inner carton), and 69097-031-17 (foil blister packs).

Am I affected

You are affected if you have a prescription bottle of Nilotinib 150 mg capsules with NDC number 69097-031-74, 69097-031-56, or 69097-031-17 printed on the label or packaging.

What to do right now

Contact your pharmacist or healthcare provider about your Nilotinib prescription. Do not stop taking the medication without medical guidance. Your provider can confirm whether your specific dose is affected and discuss next steps with you.

The hazard

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

Brands affected

Cipla USA, Inc.
Source
FDA
Category
Drugs & Medications
Recall ID
fda-D-0381-2026
Classification
Class III
Recalled
February 18, 2026
Read the official notice

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