Home / Recalls / Novartis Pharmaceuticals Corp. / D-1174-2023

D-1174-2023 Class I Ongoing

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

FDA drug recall D-1174-2023 was initiated by Novartis Pharmaceuticals Corp. on Sep 8, 2023 and is designated Class I. Reason for recall: Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. The recall status is ongoing. Affected quantity: 1272 bottles.

Recall details

Product Type: Drugs
Report Date: Sep 27, 2023
Initiation Date: Sep 8, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1272 bottles

Product description

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.

Distribution pattern

Nationwide in the USA

Code information

FX001691, Exp. 12/31/2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1174-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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