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Important FDA Safety Alert: Recall of Nilotinib Capsules

Cipla USA, Inc., in coordination with the U.S. Food and Drug Administration (FDA), has issued a voluntary recall of specific lots of Nilotinib Capsules, 150 mg. This recall, announced on March 11, 2026, is due to the product failing to meet established quality specifications during long-term stability testing.

Why Was This Medication Recalled?

The recall was initiated after the manufacturer observed “Out of Specification” (OOS) results during routine 6-month stability testing for the “Description” and “Appearance by Visual Inspection” tests. Stability testing is a critical pharmaceutical process that ensures a drug maintains its identity, strength, quality, and purity throughout its shelf life. A failure in these tests indicates the capsules may not look as they should, which can be an early warning sign of potential degradation or other quality issues that could affect the drug’s safety or effectiveness.

Nilotinib (marketed under the brand name Tasigna®) is a prescription medication used to treat certain types of Philadelphia chromosome-positive chronic myeloid leukemia (CML). It is a potent tyrosine kinase inhibitor and is not associated with the treatment of tinnitus or general hearing health conditions.

What Should You Do If You Take This Medication?

Patient safety is the top priority. If you are currently taking Nilotinib Capsules, it is crucial to follow these steps:

• DO NOT stop taking your medication abruptly. Suddenly discontinuing a prescription cancer treatment can be dangerous.
• Check your supply immediately. Compare the NDC (National Drug Code) numbers on your prescription packaging to the recalled codes listed in the safety alert box above.
  • Outer Carton: NDC 69097-031-74
  • Inner Carton: NDC 69097-031-56
  • Foil Blister: NDC 69097-031-17
• Contact your pharmacist or prescribing oncologist/hematologist. Inform them that you may have a recalled product. They will verify the lot number and advise you on how to obtain a replacement supply from a non-recalled lot.
• Do not return the medication to the pharmacy until you have spoken with your healthcare provider and have a new prescription in hand to ensure there is no gap in your treatment.

Understanding the Health Implications

The recall is classified based on a failure of quality controls, not on reports of patient harm. The “Description” and “Appearance” tests are early indicators of potential stability problems. A capsule that has changed in color, texture, or form may signal that the active ingredient is degrading or that moisture has compromised the product. Taking a degraded medication could result in it being less effective, which is a significant risk for patients managing a serious condition like CML.

There have been no reports of adverse events related to this recall to date. The action is proactive, taken by the manufacturer and the FDA to prevent any potential risk to patients.

For the hearing health community, this event serves as a reminder to always store medications properly (in a cool, dry place away from humidity and sunlight) and to regularly inspect them for any changes in color, smell, or consistency before use.

How to Report Problems

If you experience any problems you suspect are related to this medication, you are encouraged to report them to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: