Moderate riskFDA DrugMar 11, 2026Class III

Cipla USA nilotinib capsules recalled for failed appearance tests

Cipla USA is recalling specific lots of Nilotinib 150 mg capsules because testing found the capsules did not meet appearance and description standards after six months of storage. The affected lots are 5GJ0220, 5GJ0221, and 5GJ0222, with expiration date 04/30/2027. No injuries have been reported.

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

What to do

Check your Nilotinib bottle for lot numbers 5GJ0220, 5GJ0221, or 5GJ0222
Do not use capsules from these lots
Contact your pharmacy or doctor for a replacement
Call Cipla USA at the number on your prescription bottle with questions

Official notice ↗

Is yours affected?

Compare your label or packaging with the 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
Sold in: Nationwide
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Illnesses reported: None reported
Manufactured in: 10 Independence Blvd, N/A, Warren, NJ, United States
Classification: Class III
Recall number: D-0381-2026

In the FDA's words

Description: 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 Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027 Distribution: U.S.A. Nationwide Affected quantity: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
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… (this page)
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…
D-0382-2026 · 164 cartons