The Recall Desk
LowFDA (Drugs)·D-0382-2026·Announced 2026-03-11

Nilotinib 200 mg capsules recalled after failing appearance tests

Cipla USA is recalling one lot of Nilotinib Capsules 200 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: Rubric level 1 covers cosmetic defects, and this FDA Class III recall was triggered specifically by the Description and Appearance by Visual Inspection tests rather than any potency or safety specification.

Plain-English summary

Cipla USA, Inc. is recalling Nilotinib Capsules, 200 mg per capsule, prescription only. The recall covers the 112-capsule outer carton (NDC 69097-032-74), the 28-capsule inner carton (NDC 69097-032-56) and the foil blister (NDC 69097-032-17). About 164 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class III.

The recall was initiated for failed tablet/capsule specifications: out-of-specification results were observed at the six-month long-term stability condition for the Description test and the Appearance by Visual Inspection test.

Affected product is lot 5GJ0223 with an expiry date of 04/30/2027.

Patients and pharmacies can identify affected product by the NDC and lot number above, and may contact Cipla USA, Inc. for further information.

The recalled product

Product
NILOTINIB (NILOTINIB)
Brand
NILOTINIB
Manufacturer
Cipla USA, Inc.
Category
Drug — Prescription capsule
Hazard
Affected units
164

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 5GJ0223
  • Exp 04/30/2027

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cipla USA, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · NILOTINIB

Same manufacturer · Cipla USA, Inc.

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