FDA DrugsClass III
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactur...
Published: March 11, 2026Recall ID: D-0381-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Openfda › Nui › 1 | N0000175605 |
| Openfda › Nui › 2 | N0000020009 |
| Openfda › Nui › 3 | N0000187062 |
| Openfda › Nui › 4 | N0000182137 |
| Openfda › Nui › 5 | N0000187064 |
| Openfda › Nui › 6 | N0000187063 |
| Openfda › Nui › 7 | N0000191272 |
| Openfda › Nui › 8 | N0000185503 |
| Openfda › Unii | F41401512X |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 2715459 |
| Openfda › Rxcui › 2 | 2715469 |
| Openfda › Rxcui › 3 | 2715473 |
| Openfda › Spl id | d748f03e-56ba-48e2-ae13-e8e74fac55e7 |
| Openfda › Brand name | NILOTINIB |
| Openfda › Spl set id | e27c3e09-bc4f-4f01-be05-1c43ac72285d |
| Openfda › Package ndc › 1 | 69097-030-08 |
| Openfda › Package ndc › 2 | 69097-030-16 |
| Openfda › Package ndc › 3 | 69097-030-63 |
| Openfda › Package ndc › 4 | 69097-031-17 |
| Openfda › Package ndc › 5 | 69097-031-56 |
| Openfda › Package ndc › 6 | 69097-031-74 |
| Openfda › Package ndc › 7 | 69097-031-76 |
| Openfda › Package ndc › 8 | 69097-031-73 |
| Openfda › Package ndc › 9 | 69097-031-91 |
| Openfda › Package ndc › 10 | 69097-032-17 |
| Openfda › Package ndc › 11 | 69097-032-56 |
| Openfda › Package ndc › 12 | 69097-032-74 |
| Openfda › Package ndc › 13 | 69097-032-76 |
| Openfda › Package ndc › 14 | 69097-032-73 |
| Openfda › Package ndc › 15 | 69097-032-91 |
| Openfda › Product ndc › 1 | 69097-030 |
| Openfda › Product ndc › 2 | 69097-031 |
| Openfda › Product ndc › 3 | 69097-032 |
| Openfda › Generic name | NILOTINIB |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | NILOTINIB |
| Openfda › Pharm class epc | Kinase Inhibitor [EPC] |
| Openfda › Pharm class moa › 1 | Bcr-Abl Tyrosine Kinase Inhibitors [MoA] |
| Openfda › Pharm class moa › 2 | Cytochrome P450 2C8 Inhibitors [MoA] |
| Openfda › Pharm class moa › 3 | Cytochrome P450 2D6 Inhibitors [MoA] |
| Openfda › Pharm class moa › 4 | Cytochrome P450 2B6 Inducers [MoA] |
| Openfda › Pharm class moa › 5 | Cytochrome P450 2C8 Inducers [MoA] |
| Openfda › Pharm class moa › 6 | UGT1A1 Inhibitors [MoA] |
| Openfda › Pharm class moa › 7 | P-Glycoprotein Inhibitors [MoA] |
| Openfda › Manufacturer name | Cipla USA Inc. |
| Openfda › Application number | NDA218922 |
| Openfda › Is original packager | true |
| Event id | 98452 |
| Address 1 | 10 Independence Blvd |
| Address 2 | N/A |
| Code info | Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 |
| Postal code | 07059-2730 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260218 |
| Initial firm notification | Letter |
| Center classification date | 20260303 |
Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionU.S.A. Nationwide