Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence
Summary
The FDA issued a Class III for Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactur by Cipla USA, Inc.. Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Ins.
Details
Source
Drug Recall
External ID
D-0382-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 5GJ0223, Exp 04/30/2027
Quantity Affected: 164 cartons
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-18
Company
Warren, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0382-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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