East Hanover, NJ, United States
Novartis Pharmaceuticals Corporation recalls
6 recalls recorded since 2018, most recently on 4 August 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)3
Terminated or completed3
Class I (FDA)3
Ongoing Class II Drugs
- Recall started
- 4 August 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0746-2026
- Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
Ongoing Class I Drugs
- Recall started
- 22 November 2023
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover
Ongoing Class I Drugs
- Recall started
- 8 September 2023
- Reason
- Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 Hanov
Terminated Class II Drugs
- Recall started
- 16 September 2022
- Terminated
- 11 March 2024
- Reason
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Distribution
- Nationwide and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1543-2022
- Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Terminated Class III Drugs
- Recall started
- 10 May 2022
- Terminated
- 28 February 2024
- Reason
- Failed Impurities/Degradation Specifications.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0985-2022, D-0984-2022, D-0983-2022, D-0982-2022
- Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufa
- Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufa
- Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only,
- Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Ma
Terminated Class I Drugs
- Recall started
- 11 May 2019
- Terminated
- 28 November 2023
- Reason
- Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
- Distribution
- Nationwide with in the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1309-2019
- Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product o
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.