Severity
Low
LowClass IIIOngoing
FDA Drug recall · Reported March 11, 2026
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, 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 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Cipla USA, Inc. recalled Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Ci… - a low-severity action.
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Ci… was recalled by Cipla USA, Inc. in March 11, 2026. Reason: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Desc…. Check the official notice for the remedy. Verify recall #D-0381-2026 with the FDA Drug before acting.
The recall
Cipla USA, Inc. issued this low-severity FDA Drug recall-Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Desc….
- Low
- severity level
- Class III
- classification
- March 11, 2026
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0381-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0381-2026) was formally reported on March 11, 2026, with the manufacturer initiating the action on February 18, 2026. It is classified under Low severity (Class III), with a current status of Ongoing. Cipla USA, Inc. is listed as the recalling firm, operating out of Warren, NJ. Federal records list the affected scope as 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules.
The documented reason for this recall is: Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test. Distribution data in the federal record shows the product reached: U.S.A. Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules
Related Recalls
6
5 from same agency
Product description
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, 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 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Reason for recall
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | D-0381-2026 |
| Date reported | March 11, 2026 |
| Date initiated | February 18, 2026 |
| Recalling firm | Cipla USA, Inc. |
| Firm location | Warren, NJ |
| Affected scope | 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules |
| Distribution | U.S.A. Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0381-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, 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 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17. Recalled by Cipla USA, Inc.. Units affected: 271 cartons - Ex: 84 outer cartons x 4 inner cartons x 4 blisters x 7 capsules.
Why was this product recalled? ▼
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 11, 2026. Severity: Low. Recall number: D-0381-2026.
Where was the recalled product distributed? ▼
Distribution: U.S.A. Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0381-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported March 11, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.