The Recall Desk
ModerateFDA (Drugs)·D-0983-2022·Announced 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.

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: FDA Class III recall with no reported illnesses or injuries. The hazard relates to failed impurity and degradation specifications, representing a quality control issue rather than an acute safety threat.

Plain-English summary

Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast ophthalmic solution) 5% due to failed impurities and degradation specifications. The product failed quality control specifications related to impurities and product degradation.

Approximately 1.25 million vials have been distributed nationwide within the United States. The recall includes multiple lot numbers with expiration dates ranging from May 2022 through February 2023.

Patients currently using this medication should contact their healthcare provider or pharmacist to determine if their supply is affected and whether an alternative should be used.

The recalled product

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,
Manufacturer
Novartis Pharmaceuticals Corporation
Category
Drug — Ophthalmic
Hazard
Affected units
1,253,862

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)19E31
  • 19E32
  • 19E85
  • 19E86
  • 19EC0
  • 19EG8 & 19EG9
  • Exp. Date 05/2022
  • 19F13
  • 19FB0 & 19FC5
  • Exp. Date 6/2022
  • 19G33
  • 19G34
  • 19GJ8
  • Exp. Date 07/2022
  • 19M25
  • 19M26 & 19M68
  • Exp. Date 08/2022
  • 19NC0
  • 19NC1
  • 19NF2

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 manufacturer · Novartis Pharmaceuticals Corporation

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Same hazard · impurity degradation

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