FDA Drug recall D-0144-2024
SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun…
- FDA Drug
- Class I
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class I recall of SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Hun… by Novartis Pharmaceuticals, citing crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0144-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-22 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
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
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Identifiers
| code_info | Lot #: FX001500, FX001582, Exp. 09/30/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0144-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.