Cipla USA Inc. Issues Voluntary Recall for Nilotinib Capsules Due to Stability Test Failure

Source: FDA · United States

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Cipla USA Inc. is recalling specific lots of Nilotinib Capsules (150 mg) after the product failed long-term stability tests regarding its visual appearance and description.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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What Happened

Cipla USA Inc. has initiated a voluntary Class III recall of Nilotinib Capsules, 150 mg, due to failed tablet/capsule specifications. During a six-month long-term stability study, the product yielded "Out of Specification" (OOS) results for both the Description test and the Appearance by Visual Inspection test. The recall was officially initiated on February 18, 2026.

Which Products Are Affected

The recall involves 271 cartons of Nilotinib Capsules, 150 mg, distributed nationwide across the United States. The affected products are identified by the following details:

  • Product: Nilotinib Capsules, 150 mg
  • Lot Numbers: 5GJ0220, 5GJ0221, 5GJ0222
  • Expiration Date: 04/30/2027
  • NDC Numbers:
    • Outer carton (112 capsules): 69097-031-74
    • Inner carton (28 capsules): 69097-031-56
    • Foil blister: 69097-031-17
  • Manufacturer: Cipla Ltd., Verna, Goa, India, for Cipla USA, Inc.

What You Should Do

Consumers, pharmacists, and healthcare providers should check their inventory for the affected lot numbers listed above. If you have the recalled medication, you should contact Cipla USA, Inc. at their Warren, New Jersey office for guidance on returning the product. Patients currently taking this medication should consult with their physician or healthcare provider before stopping treatment to ensure a safe transition to a non-affected lot or alternative therapy.

Why This Matters

This recall is classified as Class III, which indicates that the use of or exposure to the product is not likely to cause adverse health consequences, but the product fails to meet FDA quality and appearance standards for long-term stability.

Source

Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: D-0381-2026.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cipla USA Inc. is recalling specific lots of Nilotinib Capsules (150 mg) after the product failed long-term stability tests regarding its visual appearance and description.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.