Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0982-2022·Announced 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.

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 an FDA Class III recall with no reported illnesses or injuries. The hazard involves specification failures (impurities and degradation) rather than a confirmed safety threat. Per the rubric, Class III recalls are typically scored 1-2, and this precautionary recall for quality control issues warrants a Score 2.

Plain-English summary

Novartis Pharmaceuticals Corporation is recalling 1,187,092 vials of Xiidra (lifitegrast ophthalmic solution) nationwide. The recall affects specific lot numbers of both the 60-container and 5-container package sizes (NDC 0078-0911-12 and NDC 0078-0911-05), manufactured by The Ritedose Corporation and distributed by Novartis.

The recall was initiated because these lots failed quality specifications for impurities and degradation. Affected lot numbers with various expiration dates ranging from April 2023 to November 2023 are detailed in the FDA's formal recall notice.

Patients currently using these affected lots are advised to contact their healthcare provider or pharmacist for guidance. Do not discontinue or dispose of medication without consulting your pharmacist to ensure continuity of treatment and proper handling.

The recalled product

Product: XIIDRA (LIFITEGRAST)
Brand: XIIDRA
Manufacturer: Novartis Pharmaceuticals Corporation
Category: Drug — Ophthalmic / Eye Medication
Hazard: impurities
degradation
Affected units: 1,187,092

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 (20)

Lot #:a) and b) 20E21
20E22
20E53
20E54
20E95
20E96
20ED1
20ED2
20ED3
20EK1 Exp. Date 4/2023
20F27
20F28
20F66
20F67
20FH6
Exp. Date 05/2023
20G47
20G48
20G49
20G57

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 →

Same brand · XIIDRA

Moderate
Ophthalmic Solution Xiidra Recalled for Failed Impurities and Degradation
FDA (Drugs) · 2022-06-15

Same manufacturer · Novartis Pharmaceuticals Corporation

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Xiidra ophthalmic solution recalled for failed impurity and degradation specifications
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Same hazard · impurities