Class I
Ongoing
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
This recall is currently active, issued December 13, 2023. It was issued by Novartis Pharmaceuticals Corporation.
- Recall Initiated
- November 22, 2023
- Posted
- December 13, 2023
- Recall Number
- D-0144-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 6,997 bottles
- Firm Location
- East Hanover, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: FX001500, FX001582, Exp. 09/30/2024
More recalls by Novartis Pharmaceuticals Corporation
Other recent Class I Drug recalls
UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syringe, Rx only, Manufactu...
Mckesson
· Feb 18, 2026
Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLu...
Green Lumber Holdings, Llc
· Feb 11, 2026
Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India...
Handelnine Global Llc
· Feb 11, 2026
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNat...
Medinatura New Mexico, Inc.
· Jan 14, 2026
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, L...
Fresenius Kabi Usa, Llc
· Dec 3, 2025