FDA recall, , Low risk
Cipla Nilotinib Capsules
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Summary by Recall Canary from the FDA notice
What happened
Cipla USA, Inc. of Warren, New Jersey is recalling Nilotinib Capsules in 150 mg and 200 mg strengths because the products failed specifications, with out-of-specification results observed at the 6-month long-term stability condition for the Description test and Appearance by Visual Inspection test. The recall began on February 18, 2026, and was added to the FDA's Enforcement Report on March 3, 2026. The products were distributed nationwide.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its lot code and NDC are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
Nilotinib Capsules
- Strength
- 150 mg
- NDC
- 69097-031-74
- 69097-031-56
- 69097-031-17
- Lot code
- 5GJ0220
- 5GJ0221
- 5GJ0222
- Strength
- 200 mg
- NDC
- 69097-032-74
- 69097-032-56
- 69097-032-17
- Lot code
- 5GJ0223
Recall details
- Company began the recall
- Sold in
U.S.A. Nationwide
- Company
- Cipla USA, Inc.Warren, New Jersey
- Hazard
- Quality testing problem
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98452
- Recall numbers
- D-0381-2026 to D-0382-2026
All recalls from Cipla USA, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
