Ophthalmic Solution Xiidra Recalled for Failed Impurities and Degradation
Novartis is recalling Xiidra ophthalmic solution professional samples nationwide due to failed impurities and degradation specifications.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as an FDA Class III recall with no reported illnesses or injuries, placing it in the Moderate category. The failed quality specifications warrant a precautionary recall, but the absence of reported adverse effects supports the lower severity classification.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast) ophthalmic solution 5% professional samples nationwide due to failed impurities and degradation specifications. The recall involves 279,179 vials with lot number 20DJ3 and expiration date March 2023.
The affected samples were distributed across the United States to healthcare facilities and practices. Xiidra is a prescription ophthalmic medication used to treat dry eye disease. As a professional sample product, these were intended for healthcare provider distribution and use.
The recalled product
- Product
- XIIDRA (LIFITEGRAST)
- Brand
- XIIDRA
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 279,179
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)
- Lot #: a) and b) 20DJ3
- Exp. Date 03/2023.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Novartis Pharmaceuticals Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · XIIDRA
- ModerateOphthalmic Drug Xiidra Recalled for Failed Impurity Specifications
FDA (Drugs) · 2022-06-15
Same manufacturer · Novartis Pharmaceuticals Corporation
See all →- ModerateNovartis Recalls Diovan Valsartan Tablets Due to Failed Dissolution Specifications
FDA (Drugs) · 2026-08-19
- SevereFDA Recalls SANDIMMUNE Oral Solution Due to Crystallization
FDA (Drugs) · 2023-12-13
- HighFDA Recalls Neoral Cyclosporine for Out-of-Specification Ethanol Content
FDA (Drugs) · 2022-10-05
- ModerateXiidra Ophthalmic Solution Recalled for Failed Impurity and Degradation Specifications
FDA (Drugs) · 2022-06-15
- ModerateXiidra ophthalmic solution recalled for failed impurity and degradation specifications
FDA (Drugs) · 2022-06-15
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08