What does Class III mean?

Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.

Is this recall still active?

The FDA lists the recall as ongoing. The recall is still in progress.

Checked Oct 26, 2026

Class IIIDrug recallOngoing

Nilotinib Capsules recall

Recalled by Cipla USA, Inc. of Warren, NJ · FDA report 03/11/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class: Class III; Low risk
Status: Ongoing
Recall started: 02/18/2026
Distribution: Nationwide

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.

Class III: Use of or exposure to the product is not likely to cause adverse health consequences.

Recalled product

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
Lot and code info: Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027
Quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Recall number: D-0381-2026
Event ID: 98452
Initiated by: Voluntary: Firm initiated

Where it was distributed

U.S.A. Nationwide

Nationwide

Recall timeline

02/18/2026Firm started the recall
03/03/2026FDA classified it as Class III
03/11/2026Published in the FDA enforcement report

All products in this recall

2 products under event 98452

D-0381-2026Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10... This page
D-0382-2026Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ...

More recalls from Cipla USA

Frequently asked questions

Why was Nilotinib Capsules recalled?: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
What does Class III mean?: Class III is FDA's low risk recall category: use of or exposure to the product is not likely to cause adverse health consequences.
Where was the recalled product sold?: U.S.A. Nationwide
Is this recall still active?: The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 03/11/2026 · Do not rely on openFDA to make decisions regarding medical care

Recall at a glance

Class: Class III
Status: Ongoing
Type: Drug
Reported: 03/11/2026

FDA enforcement report search

What recall classes mean

Class IMost serious: A reasonable chance that using or being exposed to the product will cause serious health problems or death.
Class IIModerate: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Class IIILow risk: Use of or exposure to the product is not likely to cause adverse health consequences.

Classes are assigned by the FDA based on the health hazard.

If you have a recalled product

Stop using or eating it. Check the lot number, UPC or date code against the recall.
Return it to the store or follow the firm's instructions for a refund, repair or disposal.
For medicines, talk to your pharmacist or doctor before stopping a prescription.
Report problems to the FDA through MedWatch or to the CPSC at SaferProducts.gov.

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About this data

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