Cipla USA Inc. Issues Nationwide Recall for Nilotinib Capsules Due to Appearance Defects
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
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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