FDA-Drug2026-03-11Class IIIPROCESSING DEFECT
Cipla Nilotinib 150 mg capsules recalled for failed stability specifications
OTHERNationwide distribution
Stop using Cipla Nilotinib 150 mg capsules
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.
- 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
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
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0381-2026More 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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