FDA-Drug2026-03-11Class IIIPROCESSING DEFECT
Cipla Nilotinib 200 mg capsules recalled for failed quality specifications
OTHERNationwide distribution
Stop using Cipla Nilotinib capsules, Lot 5GJ0223
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.
Hazard
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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 USA, Inc. recalls
- FDA-Drug2026-04-22Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
- FDA-Drug2026-04-22Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
- FDA-Drug2026-04-22Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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