CLASS I ONGOING Drug recall · Reported 27 Sep 2023 · FDA Enforcement Report
Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled
Novartis Pharmaceuticals is recalling Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, distributed nationwide in the US. The recall was initiated on 8 Sep 2023 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1174-2023
- FDA event ID
- 92975
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Sep 2023
- FDA classified
- 21 Sep 2023
- Reported
- 27 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 8 Sep 2023 | Recall initiated by company | |
| 21 Sep 2023 | Classified by FDA | +13 days |
| 27 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Product as listed by the FDA
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Which lots are affected?
FX001691, Exp. 12/31/2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Novartis Pharmaceuticals
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalled | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
Other Sandimmune (cyclosporine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |