Lower riskDrug recall · FDA · Published September 16, 2022
Novartis Recalls Neoral Capsules Due to Ethanol Content Issues
Novartis recalls Neoral soft gelatin capsules (25mg) due to ethanol content exceeding specifications during stability testing. This may affect medication safety for immunosuppressed patients.
“Novartis Recalls Neoral Capsules Due to Ethanol Content Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34321-novartis-recalls-neoral-capsules-due-to-ethanol-content-issues. Based on FDA recall #D-1543-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1543-2022%22&limit=1).
The FDA announced on Sept. 16, 2022, that Novartis Pharmaceuticals Corporation voluntarily recalled Neoral soft gelatin capsules due to manufacturing deviations. The recall affects 132,999 cartons distributed nationwide and in Puerto Rico.
Manufacturer: Novartis Pharmaceuticals Corporation, East Hanover, NJ
The hazard
The recall was initiated due to CGMP deviations involving out-of-specification results for ethanol content obtained during routine stability testing. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Novartis Pharmaceuticals Corporation has 3 other recalls on record since May 10, 2022. Other recent recalls of similar products include Diovan 160mg Tablets (Aug. 4, 2026), Sandimmune Oral Solution (Nov. 22, 2023), and Xiidra 5% Professional Sample (May 10, 2022). Other recent recalls of similar products include Duloxetine Capsules (May 14, 2026), Gelatin Capsule Pack (Feb. 19, 2026), and Duloxetine Capsules (April 29, 2026).
How to tell if you have this one
Check for Neoral soft gelatin capsules (25mg, Rx Only) with NDC # 0078-0246-15. The lot number APCD162 was produced in East Hanover, NJ and expires January 2023.
Brand
Novartis
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC number 0078-0246-15 and lot number APCD162 on the product packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-1543-2022 (September 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1543-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.