Cipla USA, Inc. is voluntarily recalling 435 cartons of Nilotinib capsules (150 mg and 200 mg) because they failed quality specifications during long-term stability testing. Specifically, the capsules did not meet the required standards for visual appearance and description during a 6-month check. This recall affects various lot numbers with expiration dates in April 2027 that were distributed nationwide in the United States.
While this is a low-risk recall, the product failed stability tests which means the physical appearance or chemical integrity of the capsules may change over time, potentially impacting the consistency of the medication.
You have 2 options:
Quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Quantity: 164 cartons
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Sources: FDA iRES · Raw API Response
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