FDA Drug · D-1174-2023

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.

Class I · Ongoing

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

Affected lots / codes — check yours against thisFX001691, Exp. 12/31/2025

Recalling firm: Novartis Pharmaceuticals Corp., East Hanover, NJ
Classification: Class I (most serious — risk of serious harm)
Status: Ongoing
Quantity: 1272 bottles
Distribution: Nationwide in the USA
Recall initiated: September 8, 2023
Classified: September 21, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1174-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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