Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
USNilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
Recalling Firm: Cipla USA, Inc.
Reason for Recall / Hazard
TranslatedFailed 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
TranslatedNilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17
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 #: 5GJ0223, Exp 04/30/2027 |
| Postal code | 07059-2730 |
| Report date | 20260311 |
| Product type | Drugs |
| Product quantity | 164 cartons |
| 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 |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (FDA Drugs).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independe...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (FDA Drugs). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Overview
- Recalling FirmCipla USA, Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionU.S.A. Nationwide
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🚨 SAFETY ALERT: Cipla USA, Inc. - Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, 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 69097-032-74; Inner carton: 28 capsules (4 blisters of 7 capsules), NDC 69097-032-56; Foil blister: NDC 69097-032-17 Check if your household is affected: https://therecallfile.com/recalls/nilotinib-capsules-200-mg-per-capsule-packaged-in-cartons-rx-only-manu/FDA-D-0382-2026
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