Cipla Nilotinib Capsules 150mg Recall: Stability Issues

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

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.

Why it’s dangerous

The capsules failed stability tests after 6 months, meaning they might show appearance issues like discoloration or changes in shape. This could affect how the medication works over time, but the recall doesn't mention immediate harm.

Who’s affected

Prescription patients using Nilotinib 150mg capsules from Cipla USA. Those with specific lot numbers (5GJ0220-5GJ0222) are most affected.

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

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.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The capsules failed stability tests after 6 months, showing appearance issues like discoloration or shape changes.

What should I do if I have this product?

Check the lot number on the carton. If it's 5GJ0220, 5GJ0221, or 5GJ0222, contact Cipla USA for instructions.

Is there a risk of serious injury?

The recall doesn't mention any risk of serious injury or harm to users.

Take action

Contact Cipla

We’ve drafted a message you can send Cipla to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0381-2026 — Cipla Cipla

Hello,

I own a Cipla that is covered by recall D-0381-2026 from Cipla.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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.

Cipla USA, Inc. recalls Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India,

Lower-risk recall