The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0984-2022·Announced 2022-06-15

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.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 2/5 (Moderate).

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 →

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