Cipla Nilotinib 200mg Capsules Recall: Stability Issues

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Cipla USA is recalling 200mg Nilotinib capsules that may have stability problems after 6 months. This could affect medication safety for patients using these prescription drugs.

Why it’s dangerous

The capsules showed quality issues after 6 months of storage. This could mean the medication doesn't work properly or has safety concerns.

Who’s affected

Patients prescribed Nilotinib 200mg capsules by a doctor. Those using the recalled lot numbers are most at risk.

How to tell if you have this one

Check the outer carton for 112 capsules (4 packs of 28 each). Look for lot number 5GJ0223 with expiration 04/30/2027. The product is prescription-only.

Brand
Cipla USA
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number and expiration date on the packaging to confirm if it's affected.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates potential stability issues after 6 months, but the product is still safe for use within the expiration date.

How do I know if I have the recalled product?

Check for lot number 5GJ0223 with expiration 04/30/2027 on the packaging.

What should I do if I have the recalled product?

The recall does not specify a remedy, so contact your doctor or pharmacist for guidance.

Take action

Contact Cipla USA

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

✉️ Open in email

Subject: Recall D-0382-2026 — Cipla USA Cipla USA

Hello,

I own a Cipla USA that is covered by recall D-0382-2026 from Cipla USA.

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-0382-2026 (February 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0382-2026 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, 200 mg per capsule, packaged in cartons, Rx only, Manufactured for: Cipla USA, Inc., 10

Lower-risk recall