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Cipla: Multiple Packaged In Cartons Capsules
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DRUG RECALLLOW

Cipla: Multiple Packaged In Cartons Capsules

Cipla recalls Nilotinib 150 mg and 200 mg capsules over failed specification tests.

What to do

Consumers who have Nilotinib Capsules 150 mg or 200 mg should stop using them and contact their healthcare provider or pharmacist for guidance. Return the product to the place of purchase or follow the recall instructions provided by Cipla USA.

Recalled
Listed
Updated
Recall No.
D-0381-2026
Agency
FDA
Firm
Cipla USA, Inc.
Recall ID
98452
Status
ONGOING

Why it was recalled

Cipla USA is recalling Nilotinib Capsules 150 mg and 200 mg due to failed tablet/capsule specifications, specifically out-of-specification results for the Description and Appearance by Visual Inspection tests observed at the 6-month long-term stability condition.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Nilotinib Capsules

StrengthNDC / UPCRecall #
150 mgNDC 69097-031-74, NDC 69097-031-56, NDC 69097-031-17D-0381-2026
200 mgNDC 69097-032-74, NDC 69097-032-56, NDC 69097-032-17D-0382-2026

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other recent recalls from Cipla USA, Inc.

All recalls from Cipla USA, Inc.

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Editorial summary by Recall Canary · summary updated 2026-08-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification