SANDIMMUNE Oral Solution — Class I drug recall D-1174-2023
Ongoing recall by Novartis Pharmaceuticals Corp., reported 2023-09-27, distributed nationwide. Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
| Recall number | D-1174-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corp., East Hanover, NJ, United States |
| Recall initiated | 2023-09-08 |
| Classified | 2023-09-21 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,272 bottles |
| NDC | 00078-0110-22 |
| Expiration dates | 2025-12-31 |
Product
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.
Reason for recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1174-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.