Lower risk Drug recall · FDA · Published September 8, 2023

Novartis Recalls Sandimmune Oral Solution Due to Crystallization Risk

Novartis recalls Sandimmune Oral Solution (100 mg/mL, 50mL bottle) due to crystallization in bottles. This may affect immunosuppressant medication safety for patients with organ transplants.

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

🇺🇸 FDA recall #D-1174-2023Drug Novartis ›

Lower-risk recall

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

Take action

Contact the company

Recalling firmNovartis Pharmaceuticals Corp.1 Health Plz · East Hanover, NJ 07936-1016

✎ GovInfoNow plain-language explainer

Novartis has recalled a specific immunosuppressant medication (Sandimmune Oral Solution) because some bottles contain crystals. This could potentially affect the medication's safety for patients who require it after organ transplants. Read more at govinfonow.com/recall/33133-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/33133-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-1174-2023

Cite this page

“Novartis Recalls Sandimmune Oral Solution Due to Crystallization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33133-novartis-recalls-sandimmune-oral-solution-due-to-crystallization-risk. Based on FDA recall #D-1174-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1174-2023%22&limit=1).

The FDA announced on Sept. 8, 2023, that Novartis Pharmaceuticals Corp. is recalling SANDIMMUNE Oral Solution due to crystallization in the bottles. The recall affects 1,272 units distributed nationwide.

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 code: FX001691
Expiration date: Exp. 12/31/2025
Manufacturer: DELPHARM Huningue S.A.S., Huningue, France
Distributor: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

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 Corp. has had 8 other recalls on record since Aug. 8, 2013. Other recent recalls of similar products include Par Health Buprenorphine Injection Recall (June 12, 2026) and Par Health Recalls Buprenorphine Injections Due to Crystallization (Sept. 8, 2026).

How to tell if you have this one

Check for the 100 mg/mL, 50 mL bottle labeled 'SANDIMMUNE Oral Solution (cyclosporine oral solution, USP)' with NDC 0078-0110-22. The product was manufactured by DELPHARM in France and distributed by Novartis.

Brand
Novartis
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Medication Label
Look for the specific product label: SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, NDC 0078-0110-22.

Where it went and when

Where it was distributed

Distributed nationwide.

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

Distributed nationwide.

Recall timeline

FDA published this recall 19 days after the firm started it.

Sep 8, 2023Firm started the recall
Sep 21, 2023FDA classified it Class I
Sep 27, 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

Is this medication safe to use?

The recall is due to crystallization in some bottles, which may affect medication consistency. Patients should not use the recalled product and contact their healthcare provider for alternatives.

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Link to this recall

<a href="https://govinfonow.com/recall/33133-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-1174-2023 (September 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1174-2023 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.