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 Capsule (150 mg)
- Model numbers
- Lot #: 5GJ0220, Lot #: 5GJ0221, Lot #: 5GJ0222, 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 tyrosine kinase inhibitor used to treat certain leukemias. This recall involves 150 mg capsules distributed in the United States.
Why This Is Dangerous
Stability-related failures can affect potency and appearance, potentially impacting drug efficacy and safety.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Patients relying on Nilotinib for cancer treatment may be affected. There is no reported injury in the notice, but the medication could be subpotent or misrepresented until resolved.
Practical Guidance
How to identify if yours is affected
- Verify packaging: outer carton 112 capsules (4 packs of 28)
- Check Lot numbers: 5GJ0220, 5GJ0221, 5GJ0222
- Check expiry: Exp 04/30/2027
- Stop using if affected and contact Cipla USA or your clinician
- Keep recall notice and packaging for records
What timeline to expect
Recall is active; no refund details provided. Follow Cipla guidance and clinician instructions. Replacement or compensation not specified.
If the manufacturer is unresponsive
- Escalate to Cipla USA customer service
- Consult your pharmacist or physician
- Document all communications and seek FDA assistance if needed
How to prevent similar issues
- Verify NDC and lot numbers before dispensing or dispensing anew
- Only purchase from licensed pharmacies
- Be aware of Rx-only recalls and return policies for prescription meds
Documentation advice
Keep recall notice, packaging, and any medical records related to the product for future reference
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Product Details
Nilotinib capsules, 150 mg, manufactured by Cipla Ltd. in Verna, Goa, India, for Cipla USA, Warren, NJ. Recall covers 271 cartons nationwide. Outer carton: 112 capsules (4 packs of 28). Inner carton: 28 capsules (4 blisters of 7). NDCs: 69097-031-74 (outer), 69097-031-56 (inner), 69097-031-17 (foil). Lot numbers: 5GJ0220, 5GJ0221, 5GJ0222. Expiration: 04/30/2027. Class III recall.
Key Facts
- Outer carton: 112 capsules (4 packs of 28)
- Inner carton: 28 capsules (4 blisters of 7)
- Lot numbers: 5GJ0220, 5GJ0221, 5GJ0222
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Safety Guide
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