Moderate riskFDA DrugMar 11, 2026Class III

Cipla Nilotinib 200 mg capsules recalled for failed quality specifications

Cipla USA is recalling Nilotinib 200 mg capsules (Lot 5GJ0223, expiring 04/30/2027) because the capsules failed quality tests during stability testing. The capsules may not meet appearance and description standards, which means their safety and effectiveness cannot be guaranteed.

From the FDA notice · Read the official notice ↗ · All Cipla recalls

What to do

Stop taking this medication if you have Lot 5GJ0223.
Contact your doctor or pharmacist right away for a replacement or alternative treatment.
Do not flush or throw away the medication—ask your pharmacist how to safely dispose of it.

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 164 cartons
Illnesses reported: None reported
Manufactured in: 10 Independence Blvd, N/A, Warren, NJ, United States
Classification: Class III
Recall number: D-0382-2026

In the FDA's words

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 Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Lot #: 5GJ0223, Exp 04/30/2027 Distribution: U.S.A. Nationwide Affected quantity: 164 cartons
Hazard: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

2 products in this recall

The agency lists each product separately. Check every one you might have.

Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 I…
D-0381-2026 · 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 070… (this page)
D-0382-2026 · 164 cartons