CLASS III ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Nilotinib Capsules recalled by Cipla USA
Cipla USA is recalling Nilotinib Capsules, distributed nationwide in the US. The recall was initiated on 18 Feb 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0381-2026
- FDA event ID
- 98452
- Recalling firm
- Cipla USA, Warren, NJ
- Brand
- Nilotinib
- Manufacturer
- Cipla USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 18 Feb 2026
- FDA classified
- 3 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Feb 2026 | Recall initiated by company | |
| 3 Mar 2026 | Classified by FDA | +13 days |
| 11 Mar 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Is Nilotinib Capsules recalled?
Yes. Cipla USA recalled Nilotinib Capsules on 18 Feb 2026. The recall is Class III and its status is Ongoing. Recall number D-0381-2026.
Why was it recalled?
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Which lots are affected?
Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cipla USA
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 30 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 60 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Hydrochloride Tablets, 90 mg recalled by Cipla USACinacalcet | Cipla USA | Nitrosamine Impurity | Nationwide |
Other Nilotinib recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Nilotinib Capsules recalled by Cipla USANilotinib | Cipla USA | Potency & Assay | Nationwide |