FDA Drug recall D-0382-2026
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 3…
- FDA Drug
- Class III
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class III recall of Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 3… by Cipla Usa, citing failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0382-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-02-18 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla Usa |
| Distribution | US |
Product
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
Reason
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Identifiers
| ndc | 69097-030-08 |
|---|---|
| ndc | 69097-030-16 |
| ndc | 69097-030-63 |
| ndc | 69097-031-17 |
| ndc | 69097-031-56 |
| ndc | 69097-031-74 |
| ndc | 69097-031-76 |
| ndc | 69097-031-73 |
| ndc | 69097-031-91 |
| ndc | 69097-032-17 |
| ndc | 69097-032-56 |
| ndc | 69097-032-74 |
| ndc | 69097-032-76 |
| ndc | 69097-032-73 |
| ndc | 69097-032-91 |
| code_info | Lot #: 5GJ0223, Exp 04/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0382-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.