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Drug FDA Class III Ongoing Failed specifications

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 69097-031-7

Cipla USA, Inc. Published Mar 11, 2026

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Cipla USA, Inc. or your place of purchase with questions, and see the source record below for full details.
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.

Affected products (1)

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

NILOTINIB · 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules

NDC: 69097-030, 69097-031, 69097-032, 69097-030-08, 69097-030-16, 69097-030-63, 69097-031-17, 69097-031-56, 69097-031-74, 69097-031-76, 69097-031-73, 69097-031-91, 69097-032-17, 69097-032-56, 69097-032-74, 69097-032-76, 69097-032-73, 69097-032-91
Code info: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Feb 18, 2026
  2. Published
    Mar 11, 2026
Recall number
D-0381-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.