Nilotinib Capsules — Class III drug recall D-0381-2026
Ongoing recall by Cipla USA, Inc., reported 2026-03-11, distributed nationwide. Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Descr
| Recall number | D-0381-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla USA, Inc., Warren, NJ, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-03 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 69097-0030, 69097-0030-08, 69097-0030-16, 69097-0030-63, 69097-0031, 69097-0031-17, 69097-0031-56, 69097-0031-73, 69097-0031-74, 69097-0031-76, 69097-0031-91, 69097-0032, 69097-0032-17, 69097-0032-56, 69097-0032-73, 69097-0032-74, 69097-0032-76, 69097-0032-91 |
| Lot numbers | 5GJ0220, 5GJ0221, 5GJ0222 |
| Expiration dates | 2027-04-30 |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0381-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.