Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only

Cipla USA, Inc. has recalled Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on March 11, 2026 and was initiated on February 18, 2026. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, with approximately 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules affected. The company behind the recall is Cipla USA, Inc., based in Warren, NJ. The FDA describes the product as: “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 con…”

Why was Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only recalled?

According to the FDA, the stated reason for the recall is: “Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.”

What should you do?

If you think you may have bought Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, compare it against the product description and identifying codes (Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Cipla USA, Inc. or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.