Cipla USA Inc. Issues Nationwide Recall for Nilotinib Capsules Due to Appearance Defects

Source: FDA · United States

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Cipla USA Inc. is recalling one lot of Nilotinib Capsules (200 mg) after stability tests revealed the product failed visual appearance and description specifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Cipla USA, Inc. has initiated a voluntary recall of Nilotinib Capsules, 200 mg, due to failed tablet and capsule specifications. The recall was triggered after 6-month long-term stability testing yielded "Out of Specification" (OOS) results during description tests and visual appearance inspections.

Which Products Are Affected

The recall involves Nilotinib Capsules (200 mg) distributed nationwide across the United States. Approximately 164 cartons are included in this action.

  • Product Name: Nilotinib Capsules, 200 mg
  • Lot Number: 5GJ0223
  • Expiration Date: 04/30/2027
  • Recall Number: D-0382-2026
  • Packaging and NDCs:
    • Outer carton (112 capsules): NDC 69097-032-74
    • Inner carton (28 capsules): NDC 69097-032-56
    • Foil blister: NDC 69097-032-17

What You Should Do

Consumers, pharmacists, and healthcare providers are advised to check their inventory for the affected lot number (5GJ0223). The firm initiated the notification process via letter on February 18, 2026. For questions regarding returns or the recall process, the recalling firm is located at 10 Independence Blvd, Suite 300, Warren, NJ 07059.

Why This Matters

This is a Class III recall, which indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences. The recall is being conducted to ensure all medication in distribution meets the manufacturer's strict physical quality and appearance standards.

Source

Information provided by the U.S. Food and Drug Administration (FDA).

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cipla USA Inc. is recalling one lot of Nilotinib Capsules (200 mg) after stability tests revealed the product failed visual appearance and description specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.