Nilotinib Capsules — Class III drug recall D-0382-2026

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-0382-2026`
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)
Quantity	164 cartons
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	`5GJ0223`
Expiration dates	`2027-04-30`

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 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-0382-2026. 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.