FDA recall D-0381-2026

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.

Distribution

U.S.A. Nationwide

Key facts

Status

Ongoing

Initiation date

2026-02-18

Report date

2026-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2026