Reported Mar 11, 2026 · Ongoing
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India,…
Cipla USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla USA, Inc. · 10 Independence Blvd · Warren, NJ · 07059-2730
Is this the product you have?
- Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only
- Manufactured byCipla Ltd., Verna, Goa, India
- Manufactured forCipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059
- Outer carton112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74
- Inner carton28 capsules (4 blisters of 7 capsules) NDC 69097-031-56
- Foil blisterNDC 69097-031-17
- Lot codes and dates
Lot #: 5GJ02205GJ02215GJ0222Exp 04/30/2027
- Amount recalled
- 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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