Lower risk Drug recall · FDA · Published November 22, 2023

Novartis Recalls Sandimmune Oral Solution Due to Crystallization Risk

Novartis recalls Sandimmune Oral Solution (100 mg/mL, 50mL) with crystallization risk. Affected lots from Huningue, France, expire 09/30/2024.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0144-2024Drug Novartis ›

Lower-risk recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

Take action

Contact the company

Recalling firmNovartis Pharmaceuticals Corporation1 Health Plz · East Hanover, NJ 07936-1016

✎ GovInfoNow plain-language explainer

Novartis has recalled a specific dose of Sandimmune Oral Solution (cyclosporine) due to crystals forming in the bottles. This could cause issues for patients taking immunosuppressants, as crystals might affect the medication's safety and effectiveness. Read more at govinfonow.com/recall/32941-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32941-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0144-2024

Cite this page

“Novartis Recalls Sandimmune Oral Solution Due to Crystallization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32941-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk. Based on FDA recall #D-0144-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0144-2024%22&limit=1).

The FDA announced on 2023-11-22 that Novartis Pharmaceuticals Corporation is recalling SANDIMMUNE Oral Solution due to crystallization in the bottles. The agency issued recall number D-0144-2024 for the Class I voluntary recall.

How to tell if you have it

Brand: Novartis
Product: SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL
Size: 50 mL bottle
NDC: 0078-0110-22
Lot codes: FX001500, FX001582
Expiration date: 09/30/2024
Manufacturer: DELPHARM Huningue S.A.S., Huningue, France
Distributor: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936
Units affected: 6,997 bottles

The hazard

Bottles of Sandimmune Oral Solution were determined to contain crystals. The recall is classified as Class I.

Context

GovInfoNow's records show Novartis Pharmaceuticals Corporation has issued three other recalls since 2022-05-10, including Diovan 160mg Tablets on 2026-08-04 and Neoral Capsules on 2022-09-16. Other recent recalls of similar products include Par Health Buprenorphine Injections (2026-09-08), Rising Pharma Cyproheptadine Syrup (2026-07-13), and another Par Health Buprenorphine Injection recall (2026-06-12).

How to tell if you have this one

Check for the product name 'Sandimmune Oral Solution', 100 mg/mL concentration, 50 mL bottle, and lot numbers FX001500 or FX001582. The expiration date is 09/30/2024.

Brand
Novartis
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the lot number and expiration date on the bottle label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 21 days after the firm started it.

Nov 22, 2023Firm started the recall
Dec 7, 2023FDA classified it Class I
Dec 13, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have this product?

Contact Novartis directly to confirm if your product is affected and follow their instructions.

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Link to this recall

<a href="https://govinfonow.com/recall/32941-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk">Novartis Recalls Sandimmune Oral Solution Due to Crystallization Risk (GovInfoNow)</a>

Where this comes from

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-0144-2024 (November 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0144-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.