Novartis Withdraws SANDIMMUNE Oral Solution Bottles Due to Crystallization
Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as a Class I recall, which mandates a minimum severity score of 4. Although no illnesses or injuries are reported in the source, the crystallization found in bottles represents a defect in a prescription medication requiring Class I action.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL distributed nationwide. The 50 mL bottles were found to contain crystals.
The recall affects 1,272 bottles with product code FX001691 and an expiration date of December 31, 2025.
Patients who have affected bottles should contact their pharmacy or prescriber immediately. Do not use the medication without guidance from your healthcare provider. Healthcare providers should verify lot codes in their inventory and remove affected product from dispensing.
The recalled product
- 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.
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 1,272
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- FX001691
- Exp. 12/31/2025
Distribution
Distributed nationwide across the United States.
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