Quick Facts at a Glance
- Recall Date
- February 18, 2026
- Hazard Level
- HIGH
- Brands
- Nilotinib, Cipla USA
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Nilotinib, Cipla USA
- Product type
- Nilotinib Capsules 200 mg (Rx)
- Model numbers
- Lot #: 5GJ0223, Exp 04/30/2027
- UPC codes
- 69097-030, 69097-031, 69097-032, 69097-030-08, 69097-030-16, 69097-030-63, 69097-031-17, 69097-031-56 +5 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 18, 2026
Reported by FDA DRUG
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
About This Product
Nilotinib is a prescription medicine used to treat certain leukemias. This recall focuses on a quality-control issue affecting stability and appearance.
Why This Is Dangerous
A six-month stability failure may affect the description and visual appearance of the capsules, potentially impacting potency or quality.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
No injuries or deaths reported in the recall. The quality issue could affect treatment effectiveness if affected packaging is used.
Practical Guidance
How to identify if yours is affected
- Check Lot number 5GJ0223 and Expiration date 04/30/2027.
- Confirm packaging details match recall notice (outer carton 112 capsules, inner carton 28 capsules).
Where to find product info
NDCs, lot number, and expiration date are printed on the packaging. FDA recall page linked in the notice provides official details.
What timeline to expect
Recall is active. Replacement or guidance will be provided by Cipla USA; no refund information is provided for prescription medication.
If the manufacturer is unresponsive
- Escalate to your pharmacist or healthcare provider if the company is unresponsive.
- Report issues to the FDA if you suspect quality concerns persist.
How to prevent similar issues
- Verify NDC numbers when receiving prescriptions.
- Monitor for recall updates from Cipla USA and the FDA.
- Consult healthcare providers before changing therapy due to recall.
Documentation advice
Keep the recall notice, packaging, lot and expiration dates, and all correspondence with Cipla USA for records.
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Product Details
Rx-only Nilotinib capsules, 200 mg per capsule. Outer carton contains 112 capsules (4 packs of 28). Inner carton contains 28 capsules (4 blisters of 7). NDCs: 69097-032-74 (outer), 69097-032-56 (inner), 69097-032-17 (foil blister). Lot number: 5GJ0223. Expiration: 04/30/2027. Quantity recalled: 164 cartons. Sold nationwide in the USA. Distributed by Cipla USA, Inc., Warren, NJ. Model numbers are not applicable; packaging references. Status: Active recall with Class III designation.
Key Facts
- Distribution: USA nationwide
- Classification: Class III recall
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