Nilotinib capsules recalled after failing appearance tests at six months
Cipla USA is recalling three lots of Nilotinib Capsules 150 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Rubric level 1 covers cosmetic defects, and this FDA Class III recall was triggered specifically by the Description and Appearance by Visual Inspection tests rather than any potency or safety specification.
Plain-English summary
Cipla USA, Inc. is recalling Nilotinib Capsules, 150 mg per capsule, prescription only, manufactured by Cipla Ltd. of Verna, Goa, India. The recall covers the 112-capsule outer carton (NDC 69097-031-74), the 28-capsule inner carton (NDC 69097-031-56) and the foil blister (NDC 69097-031-17). About 271 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class III.
The recall was initiated for failed tablet/capsule specifications: out-of-specification results were observed at the six-month long-term stability condition for the Description test and the Appearance by Visual Inspection test.
Affected product covers lots 5GJ0220, 5GJ0221 and 5GJ0222, with an expiry date of 04/30/2027.
Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Cipla USA, Inc. for further information.
The recalled product
- Product
- NILOTINIB (NILOTINIB)
- Brand
- NILOTINIB
- Manufacturer
- Cipla USA, Inc.
- Category
- Drug — Prescription capsule
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 5GJ0220
- 5GJ0221
- 5GJ0222
- Exp 04/30/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Cipla USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · NILOTINIB
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