Why Is Xiidra Recalled? Understanding the 2022 FDA Class III Action

October 7, 2025 •

4 min read

In June 2022, Novartis Pharmaceuticals initiated a voluntary recall of dozens of lots of the prescription dry eye medication Xiidra (lifitegrast ophthalmic solution) after it was discovered they failed to meet specifications for impurities/degradation. The U.S. Food and Drug Administration (FDA) designated this action as a Class III recall, indicating that use of the affected product was not likely to cause harm.

Quick Summary

Dozens of Xiidra lots were recalled in 2022 for failing quality specifications regarding impurities or degradation. The FDA classified this as a low-risk Class III recall, distinguishing it from more serious, recent eye drop recalls involving sterility or contamination concerns.

Key Points

Reason for Recall: The 2022 Xiidra recall by Novartis was due to affected lots failing to meet specifications for impurities/degradation, not sterility.
FDA Classification: The recall was classified as a low-risk Class III by the FDA, meaning use of the product was not likely to cause harm.
Low Health Risk: Unlike other, more serious eye drop recalls, the Xiidra issue did not involve bacterial or fungal contamination that could lead to vision loss.
Affected Lots: The recall involved specific lots manufactured in 2022, which have long since expired.
Differentiating Recalls: The Xiidra recall should not be confused with more recent, higher-risk recalls of other over-the-counter and prescription eye drops related to sterility issues.
Action for Patients: As the affected lots have expired, there is no immediate action required for patients using current Xiidra prescriptions.
Recall Details: The full list of lot numbers was made public via an FDA Enforcement Report in June 2022.

Background on the 2022 Xiidra Recall

The 2022 recall of Xiidra, a prescription eye drop used to treat dry eye disease, was initiated by manufacturer Novartis due to specific quality control issues. This was not a general recall for all Xiidra products, but targeted only a number of specific lots that were distributed throughout the United States. The official FDA Enforcement Report on June 15, 2022, detailed the company's action.

The Reason for the Recall: Impurities and Degradation

The core issue prompting the recall was that specific batches of the product failed to meet the manufacturer's quality specifications for impurities and degradation. This means that over time, the chemical composition of the medicine within these particular lots had likely changed slightly, exceeding acceptable limits. These impurities were not found to pose a significant health risk to patients, which is a key factor in the FDA's classification of the recall.

FDA Classification: A Class III Recall

The FDA's classification system for recalls is based on the potential health risk to consumers. The Xiidra recall was labeled as Class III, which is the lowest risk category.

FDA Recall Classes:

Class I: Involves dangerous products that could cause serious health problems or death. This was the case with several high-profile eye drop recalls involving bacterial contamination.
Class II: Involves products that might cause temporary health problems or pose a slight threat of serious harm.
Class III: Involves products that are unlikely to cause any adverse health reactions, but violate FDA labeling or manufacturing laws.

Distinguishing the Xiidra Recall from Other Eye Drop Recalls

It is critical to distinguish the 2022 Xiidra recall from other, more concerning recalls of eye drops that have occurred both before and since. Many other recalls have been due to serious problems such as contamination and a lack of sterility assurance. These are often associated with a much higher risk of serious health consequences, including infection, vision loss, or blindness. The Xiidra recall was not related to sterility or bacterial contamination issues. Instead, it was an isolated quality control matter that the FDA deemed to be a low risk.

Comparing Xiidra's 2022 Recall with Other Ophthalmic Recalls


Feature	Xiidra Recall (Novartis, 2022)	Ophthalmic Recall (AvKARE, May 2025)	Over-the-counter Eye Drop Recall (Global Pharma, 2023)
Company	Novartis Pharmaceuticals	AvKARE (distributor)	Global Pharma Healthcare
Reason	Failure to meet specifications for impurities/degradation	Lack of assurance of sterility due to cGMP deviations	Insanitary manufacturing conditions and bacterial contamination
FDA Class	Class III	Class II	High-risk (implied, as FDA warned against use)
Risk of Harm	Unlikely to cause harm	Remote probability of serious consequences	Potential for serious infections, partial vision loss, or blindness
Manufacturer	The Ritedose Corporation	BRS Analytical Services, LLC	Kilitch Healthcare India Limited
Resolution	Voluntarily recalled by the company	Voluntarily recalled by the company	Voluntary recall after FDA warning

What to Do If You Have Recalled Xiidra

Since the recall occurred in 2022, it is highly unlikely that patients currently possess any of the affected lots, which have since expired. However, in general for any drug recall, patients should follow a few standard procedures:

Do not use the product. The primary instruction from the manufacturer is to immediately stop using the recalled product.
Verify the lot number. Check the product's box or packaging for the lot and expiration date to confirm if it is among the recalled batches.
Contact your pharmacist or healthcare provider. They can provide guidance on returning the product and obtaining a new, unaffected supply.
Properly dispose of the medication. Your pharmacist can advise on safe disposal methods.

Conclusion

The recall of Xiidra in 2022 by Novartis was a specific, low-risk event triggered by a failure to meet impurities specifications, not a sterility issue like many other eye drop recalls. The FDA's Class III designation confirmed that the potential for adverse health consequences was minimal. Patients with dry eye disease should continue to consult their healthcare providers for the appropriate treatment options and verify any potential recalls with reliable sources like the FDA or their pharmacist. The low-risk nature of the Xiidra recall underscores the importance of correctly understanding the cause and classification of recalls to avoid unnecessary alarm, especially when other, more serious eye drop contamination events have occurred in recent years.

Visit the FDA website for more information on drug safety and recalls

Affected Lots

The lots affected by the 2022 Xiidra recall were extensive, with expiration dates ranging from mid-2022 to late 2023. This included:

Cartons of 60 and 5 single-use containers (NDC 0078-0911-12 and -05) with various lot numbers.
Professional samples in 5 and 4x5 single-use containers (NDC 0078-0911-95 and -94) with a specific lot number.
Additional lots manufactured for Shire US Inc., which was acquired by Novartis.

A full list of affected lots can be found on the FDA's enforcement report for June 15, 2022.

What to Do Next

Check your medicine cabinet: While unlikely, confirm you do not have any old Xiidra packaging with lot numbers from the recall list.
Consult your doctor: If you have concerns about your dry eye treatment, discuss current options with your healthcare provider.
Use reliable sources: Verify all recall information through official sources like the FDA or the manufacturer's website.

Frequently Asked Questions

No, Xiidra was recalled in 2022 by its manufacturer, Novartis. All of the affected lots have long since expired.

The recall was initiated because specific lots of the product failed to meet quality specifications for impurities or degradation. It was not due to bacterial contamination.

The FDA classified the Xiidra recall as Class III, its lowest level of recall. This indicates that the use of the product was not likely to cause harm to patients.

No, the 2022 Xiidra recall was not related to sterility or contamination issues and was not associated with a risk of blindness or serious infection, unlike other eye drop recalls.

You would need to check the lot number and expiration date on your Xiidra packaging against the list released in the FDA's June 2022 enforcement report. However, since the recall is several years old, any affected lots would have expired by now.

Yes, if you have a current, non-expired prescription for Xiidra, it is safe to use. The recalled batches were manufactured in 2022 and have been off the market for a long time.

The Xiidra recall was a minor quality issue (Class III) concerning impurities and degradation. In contrast, many other eye drop recalls in recent years involved severe risks, such as life-threatening bacterial contamination, resulting in higher-level Class I or Class II actions.