Lower risk Drug recall · FDA · Published February 18, 2026

Cipla Nilotinib Capsules 150mg Recall: Stability Issues

Cipla USA recalls 150mg Nilotinib capsules with stability concerns. Products may show appearance issues after 6 months. Check NDC 69097-031-74 for affected lots.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0381-2026Drug Cipla ›

Lower-risk recall

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Take action

Contact the company

Recalling firmCipla USA, Inc.10 Independence Blvd · Warren, NJ 07059-2730

✎ GovInfoNow plain-language explainer

Cipla USA recalls 150mg Nilotinib capsules that failed stability tests after 6 months. This could mean the capsules look or function incorrectly over time, but the recall doesn't specify immediate harm. Read more at govinfonow.com/recall/31475-cipla-nilotinib-capsules-150mg-recall-stability-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/31475-cipla-nilotinib-capsules-150mg-recall-stability-issues · Updated August 17, 2026 · FDA enforcement record: FDA #D-0381-2026

Cite this page

“Cipla Nilotinib Capsules 150mg Recall: Stability Issues.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31475-cipla-nilotinib-capsules-150mg-recall-stability-issues. Based on FDA recall #D-0381-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0381-2026%22&limit=1).

The FDA announced on Feb. 18, 2026, that Cipla USA, Inc. is recalling Nilotinib Capsules, 150 mg, due to failed tablet and capsule specifications. The agency stated the product exhibited out-of-specification results for description and appearance tests during long-term stability conditions.

How to tell if you have it

Brand: Cipla
Product: Nilotinib Capsules, 150 mg per capsule
Lot codes: 5GJ0220, 5GJ0221, 5GJ0222
Expiration date: 04/30/2027
NDCs: 69097-031-74 (outer carton), 69097-031-56 (inner carton), 69097-031-17 (foil blister)
Quantity: 271 cartons
Distribution: U.S.A. Nationwide

The hazard

According to the FDA, the recall addresses failed tablet and capsule specifications. The agency reported observed out-of-specification results at six-months long-term stability conditions for the description test and appearance by visual inspection test.

Context

GovInfoNow's records show Cipla USA, Inc. has had 12 other recalls on record since June 27, 2023. Recent brand recalls include a Cinacalcet Tablets recall on June 29, 2026, and another Cinacalcet Tablets recall on March 16, 2026, both citing N-nitroso contamination risks. Other recent recalls of similar products include a Phytonadione Injectable Emulsion recall (Oct. 31, 2025), an Apotex Paxil CR 37.5mg Tablets recall (Aug. 13, 2026), and a Mylan Prasugrel Tablets recall (Aug. 17, 2026).

How to tell if you have this one

Check for NDC 69097-031-74 on the outer carton. Affected lots are 5GJ0220, 5GJ0221, 5GJ0222 with expiration 04/30/2027.

Brand
Cipla
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Ongoing
Distribution
U.S.A. Nationwide
NDC
69097-030-08, 69097-030-16, 69097-030-63, 69097-031-17, 69097-031-56, 69097-031-74, 69097-031-76, 69097-031-73, 69097-031-91, 69097-032-17, 69097-032-56, 69097-032-74, 69097-032-76, 69097-032-73, 69097-032-91

Recall number	Product, codes & lots	Quantity
D-0381-2026	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; Lot #: 5GJ0220, 5GJ0221, 5GJ0222, Exp 04/30/2027	271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
D-0382-2026	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; Lot #: 5GJ0223, Exp 04/30/2027	164 cartons

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 5GJ0220, 5GJ0221, or 5GJ0222 on the capsule carton.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “U.S.A. Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Feb 18, 2026Firm started the recall
Mar 3, 2026FDA classified it Class III
Mar 11, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31475-cipla-nilotinib-capsules-150mg-recall-stability-issues">Cipla Nilotinib Capsules 150mg Recall: Stability Issues (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0381-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0381-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.