Cipla USA Inc. Issues Voluntary Recall for Nilotinib Capsules Due to Stability Test Failure
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, prescription-drug.
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 ↗
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