FDA-Drug2026-03-11Class IIIPROCESSING DEFECT
Cipla Nilotinib 200 mg capsules recalled for failed quality specifications
What this means
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.
- 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.
The agency's original wording
Hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S.A. Nationwide
Affected count
164 cartons
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0382-2026More Cipla recalls
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 60 mg tablets recalled for N-nitroso impurity above safe limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 90 mg tablets recalled for N-nitroso impurity above acceptable limits
- FDA-Drug2026-07-08Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for N-nitroso impurity
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