The Recall Desk

Manufacturer

Novartis Pharmaceuticals Corporation

7 recalls in our database name Novartis Pharmaceuticals Corporation as the manufacturing or recalling firm.

What the numbers show

Total
7
Critical
0
Severe
1
Most recent
2026-08-19

Of the 7 recalls from Novartis Pharmaceuticals Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (14%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–7 of 7

  • SevereFDA (Drugs)·D-0144-2024·2023-12-13

    FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization

    Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1543-2022·2022-10-05

    FDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content

    Novartis is recalling Neoral cyclosporine 25 mg capsules nationwide due to a manufacturing quality deviation. Lot APCD162 (expiration 01/2023) was found to have out-of-specification ethanol content during stability testing.

    Product
    NEORAL — NEORAL (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0985-2022·2022-06-15

    Xiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications

    Novartis is recalling Xiidra (lifitegrast ophthalmic solution) 5% professional samples nationwide due to failed impurities and degradation quality specifications. The recall affects 279,179 vials across three lot numbers.

    Product
    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, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 0242
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0983-2022·2022-06-15

    Xiidra ophthalmic solution recalled for failed impurity and degradation specifications

    Novartis recalls approximately 1.25 million vials of Xiidra ophthalmic solution nationwide due to failed impurity and degradation specifications. Patients using this product should contact their healthcare provider.

    Product
    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, Manufactured for: Shire US Inc., 300 Shire Way, Lexington,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0982-2022·2022-06-15

    Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications

    Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.

    Product
    XIIDRA — XIIDRA (LIFITEGRAST)
    Category
    Drug
    Distribution
    Distributed nationwide