Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported October 5, 2022
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Novartis Pharmaceuticals Corporation recalled Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 So… - a moderate-severity action.
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 So… was recalled by Novartis Pharmaceuticals Corporation in October 5, 2022. Reason: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.. Check the official notice for the remedy. Verify recall #D-1543-2022 with the FDA Drug before acting.
The recall
Novartis Pharmaceuticals Corporation issued this moderate-severity FDA Drug recall-CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content..
- Moderate
- severity level
- Class II
- classification
- October 5, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1543-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1543-2022) was formally reported on October 5, 2022, with the manufacturer initiating the action on September 16, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Novartis Pharmaceuticals Corporation is listed as the recalling firm, operating out of East Hanover, NJ. Federal records list the affected scope as 132,999 cartons.
The documented reason for this recall is: CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content. Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
132,999 cartons
Related Recalls
6
5 from same agency
Product description
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Reason for recall
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1543-2022 |
| Date reported | October 5, 2022 |
| Date initiated | September 16, 2022 |
| Recalling firm | Novartis Pharmaceuticals Corporation |
| Firm location | East Hanover, NJ |
| Affected scope | 132,999 cartons |
| Distribution | Nationwide and Puerto Rico |
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-1543-2022) 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? ▼
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.. Recalled by Novartis Pharmaceuticals Corporation. Units affected: 132,999 cartons.
Why was this product recalled? ▼
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 5, 2022. Severity: Moderate. Recall number: D-1543-2022.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1543-2022) 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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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 October 5, 2022. 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.