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Nilotinib Capsules, 200 mg per capsule Recall 2026

Cipla USA, Inc.Issued February 18, 2026Updated Reviewed by the Recall Watch editorial team

Cipla USA, Inc. 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 individua — recalled per FDA on 2/18/2026. Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test..

Agency
FDA
Issued
Feb 18, 2026
Brand
Cipla USA, Inc.
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued February 18, 2026 · Last synced Nov 1, 2026

What's recalled

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

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Why it was recalled

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

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot #: 5GJ0223
Exp 04/30/2027
Where was it sold
1 state

U.S.A. Nationwide

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the Cipla USA, Inc. recall still active?

Yes, this recall is currently active as of February 18, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 5GJ0223, Exp 04/30/2027. Check the label on your product.

What should I do if I have the recalled Cipla USA, Inc.?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.