Medications & Supplements/Prescription Drugs

Xiidra Ophthalmic Solution Recalled for Failed Impurity Specifications

Agency Publication Date: June 6, 2022

Summary

Novartis Pharmaceuticals Corporation has recalled approximately 2,999,312 vials of Xiidra (lifitegrast ophthalmic solution) because the product failed to meet specifications for impurities and degradation. This recall affects various packaging sizes of the prescription eye drops, including professional samples provided by healthcare providers. No incidents or injuries related to this issue have been reported to date. Consumers using this medication should verify their lot numbers and expiration dates to determine if their specific product is included in the recall.

Risk

The product failed impurity and degradation specifications, meaning the solution contains levels of chemical breakdown that fall outside of authorized safety standards. While the risk of serious health consequences is considered low, using eye drops with unintended impurities could potentially lead to irritation or reduced effectiveness of the medication.

What You Should Do

This recall affects Xiidra (lifitegrast ophthalmic solution) eye drops and Xiidra 5% Professional Samples sold in various single-use container quantities.
Identify your product by checking the NDC codes printed on the packaging, which include 0078-0911-12, 0078-0911-05, 54092-606-01, 54092-606-06, 0078-0911-95, 0078-0911-94, 54092-606-07, and 54092-606-04.
Check the lot number and expiration date printed on the individual pouches or the outer carton. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Novartis Pharmaceuticals Corporation for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xiidra (lifitegrast ophthalmic solution)

Variants: 60 Single-Use Containers (0.2 mL each), 5 Single-Use Containers (0.2 mL each)

Lot Numbers:

20E21 (Exp 4/2023)

20E22 (Exp 4/2023)

20E53 (Exp 4/2023)

20E54 (Exp 4/2023)

20E95 (Exp 4/2023)

20E96 (Exp 4/2023)

20ED1 (Exp 4/2023)

20ED2 (Exp 4/2023)

20ED3 (Exp 4/2023)

20EK1 (Exp 4/2023)

20F27 (Exp 05/2023)

20F28 (Exp 05/2023)

20F66 (Exp 05/2023)

20F67 (Exp 05/2023)

20FH6 (Exp 05/2023)

20G47 (Exp 06/2023)

20G48 (Exp 06/2023)

20G49 (Exp 06/2023)

20G57 (Exp 06/2023)

20GB8 (Exp 06/2023)

20GE5 (Exp 06/2023)

20GE6 (Exp 06/2023)

20M41 (Exp 07/2023)

20M42 (Exp 07/2023)

20M56 (Exp 07/2023)

20M66 (Exp 07/2023)

20M67 (Exp 07/2023)

20MA4 (Exp 07/2023)

20S20 (Exp 10/2023)

20S22 (Exp 10/2023)

20S44 (Exp 10/2023)

20S94 (Exp 10/2023)

20SA6 (Exp 10/2023)

20SA7 (Exp 10/2023)

20SE0 (Exp 10/2023)

20TE2 (Exp 11/2023)

20TG5 (Exp 11/2023)

NDC:

0078-0911-12

0078-0911-05

Recall #: D-0982-2022; Distributed by Novartis Pharmaceuticals Corporation.

Product: Xiidra (lifitegrast ophthalmic solution) 5%

Variants: 60 Single-Use Containers (0.2 mL each), 5 Single-Use Containers (0.2 mL each)

Lot Numbers:

19E31 (Exp 05/2022)

19E32 (Exp 05/2022)

19E85 (Exp 05/2022)

19E86 (Exp 05/2022)

19EC0 (Exp 05/2022)

19EG8 (Exp 05/2022)

19EG9 (Exp 05/2022)

19F13 (Exp 6/2022)

19FB0 (Exp 6/2022)

19FC5 (Exp 6/2022)

19G33 (Exp 07/2022)

19G34 (Exp 07/2022)

19GJ8 (Exp 07/2022)

19M25 (Exp 08/2022)

19M26 (Exp 08/2022)

19M68 (Exp 08/2022)

19NC0 (Exp 09/2022)

19NC1 (Exp 09/2022)

19NF2 (Exp 09/2022)

19NF3 (Exp 09/2022)

19P26 (Exp 10/2022)

19P59 (Exp 10/2022)

19P60 (Exp 10/2022)

19P85 (Exp 10/2022)

19P86 (Exp 10/2022)

19P87 (Exp 10/2022)

19S55 (Exp 11/2022)

19S03 (Exp 11/2022)

19S04 (Exp 11/2022)

19S05 (Exp 11/2022)

19S07 (Exp 11/2022)

19T06 (Exp 12/2022)

19T60 (Exp 12/2022)

19T61 (Exp 12/2022)

20A38 (Exp 01/2023)

20A39 (Exp 01/2023)

20A64 (Exp 01/2023)

20A65 (Exp 01/2023)

20AA1 (Exp 01/2023)

20AA2 (Exp 01/2023)

20AC8 (Exp 01/2023)

20AC9 (Exp 01/2023)

20AE7 (Exp 01/2023)

20B24 (Exp 02/2023)

20B25 (Exp 02/2023)

20B55 (Exp 02/2023)

20B56 (Exp 02/2023)

20B57 (Exp 02/2023)

20B58 (Exp 02/2023)

NDC:

54092-606-01

54092-606-06

Recall #: D-0983-2022; Manufactured for Shire US Inc.

Product: Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample

Variants: 5 Single-Use Containers (0.2 mL each), 4 pouches x 5 Single-Use Containers

Lot Numbers:

20DJ3 (Exp 03/2023)

NDC:

0078-0911-95

0078-0911-94

Recall #: D-0984-2022; Distributed by Novartis Pharmaceuticals Corporation.

Product: Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample

Variants: 5 Single-Use Containers (0.2 mL each), 4 pouches x 5 Single-Use Containers

Lot Numbers:

19F39 (Exp 06/2022)

19P27 (Exp 10/2022)

20CD1 (Exp 03/2023)

NDC:

54092-606-07

54092-606-04

Recall #: D-0985-2022; Manufactured for Shire US Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90176

Status: Resolved

Manufacturer: Novartis Pharmaceuticals Corporation

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 4 products (1,187,092 vials; 1,253,862 vials; 279,179 vials; 279,179 vials)

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects Xiidra (lifitegrast ophthalmic solution) eye drops and Xiidra 5% Professional Samples sold in various single-use container quantities.

Identify your product by checking the NDC codes printed on the packaging, which include 0078-0911-12, 0078-0911-05, 54092-606-01, 54092-606-06, 0078-0911-95, 0078-0911-94, 54092-606-07, and 54092-606-04.

Check the lot number and expiration date printed on the individual pouches or the outer carton. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Novartis Pharmaceuticals Corporation for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Xiidra (lifitegrast ophthalmic solution)

Variants: 60 Single-Use Containers (0.2 mL each), 5 Single-Use Containers (0.2 mL each)

Lot Numbers:

20E21 (Exp 4/2023)

20E22 (Exp 4/2023)

20E53 (Exp 4/2023)

20E54 (Exp 4/2023)

20E95 (Exp 4/2023)

20E96 (Exp 4/2023)

20ED1 (Exp 4/2023)

20ED2 (Exp 4/2023)

20ED3 (Exp 4/2023)

20EK1 (Exp 4/2023)

20F27 (Exp 05/2023)

20F28 (Exp 05/2023)

20F66 (Exp 05/2023)

20F67 (Exp 05/2023)

20FH6 (Exp 05/2023)

20G47 (Exp 06/2023)

20G48 (Exp 06/2023)

20G49 (Exp 06/2023)

20G57 (Exp 06/2023)

20GB8 (Exp 06/2023)

20GE5 (Exp 06/2023)

20GE6 (Exp 06/2023)

20M41 (Exp 07/2023)

20M42 (Exp 07/2023)

20M56 (Exp 07/2023)

20M66 (Exp 07/2023)

20M67 (Exp 07/2023)

20MA4 (Exp 07/2023)

20S20 (Exp 10/2023)

20S22 (Exp 10/2023)

20S44 (Exp 10/2023)

20S94 (Exp 10/2023)

20SA6 (Exp 10/2023)

20SA7 (Exp 10/2023)

20SE0 (Exp 10/2023)

20TE2 (Exp 11/2023)

20TG5 (Exp 11/2023)

NDC:

0078-0911-12

0078-0911-05

Recall #: D-0982-2022; Distributed by Novartis Pharmaceuticals Corporation.

Product: Xiidra (lifitegrast ophthalmic solution) 5%

Variants: 60 Single-Use Containers (0.2 mL each), 5 Single-Use Containers (0.2 mL each)

Lot Numbers:

19E31 (Exp 05/2022)

19E32 (Exp 05/2022)

19E85 (Exp 05/2022)

19E86 (Exp 05/2022)

19EC0 (Exp 05/2022)

19EG8 (Exp 05/2022)

19EG9 (Exp 05/2022)

19F13 (Exp 6/2022)

19FB0 (Exp 6/2022)

19FC5 (Exp 6/2022)

19G33 (Exp 07/2022)

19G34 (Exp 07/2022)

19GJ8 (Exp 07/2022)

19M25 (Exp 08/2022)

19M26 (Exp 08/2022)

19M68 (Exp 08/2022)

19NC0 (Exp 09/2022)

19NC1 (Exp 09/2022)

19NF2 (Exp 09/2022)

19NF3 (Exp 09/2022)

19P26 (Exp 10/2022)

19P59 (Exp 10/2022)

19P60 (Exp 10/2022)

19P85 (Exp 10/2022)

19P86 (Exp 10/2022)

19P87 (Exp 10/2022)

19S55 (Exp 11/2022)

19S03 (Exp 11/2022)

19S04 (Exp 11/2022)

19S05 (Exp 11/2022)

19S07 (Exp 11/2022)

19T06 (Exp 12/2022)

19T60 (Exp 12/2022)

19T61 (Exp 12/2022)

20A38 (Exp 01/2023)

20A39 (Exp 01/2023)

20A64 (Exp 01/2023)

20A65 (Exp 01/2023)

20AA1 (Exp 01/2023)

20AA2 (Exp 01/2023)

20AC8 (Exp 01/2023)

20AC9 (Exp 01/2023)

20AE7 (Exp 01/2023)

20B24 (Exp 02/2023)

20B25 (Exp 02/2023)

20B55 (Exp 02/2023)

20B56 (Exp 02/2023)

20B57 (Exp 02/2023)

20B58 (Exp 02/2023)

NDC:

54092-606-01

54092-606-06

Recall #: D-0983-2022; Manufactured for Shire US Inc.

Product: Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample

Variants: 5 Single-Use Containers (0.2 mL each), 4 pouches x 5 Single-Use Containers

Lot Numbers:

20DJ3 (Exp 03/2023)

NDC:

0078-0911-95

0078-0911-94

Recall #: D-0984-2022; Distributed by Novartis Pharmaceuticals Corporation.

Product: Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample

Variants: 5 Single-Use Containers (0.2 mL each), 4 pouches x 5 Single-Use Containers

Lot Numbers:

19F39 (Exp 06/2022)

19P27 (Exp 10/2022)

20CD1 (Exp 03/2023)

NDC:

54092-606-07

54092-606-04

Recall #: D-0985-2022; Manufactured for Shire US Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90176

Status: Resolved

Manufacturer: Novartis Pharmaceuticals Corporation

Sold By: Pharmacies; Healthcare Providers

Manufactured In: United States

Units Affected: 4 products (1,187,092 vials; 1,253,862 vials; 279,179 vials; 279,179 vials)

Distributed To: Nationwide