Why is Klarity-C being discontinued? Understanding the Manufacturer Recall and Patient Transition

October 7, 2025 •

3 min read

Following a May 2024 Class II voluntary recall of Klarity-C (cyclosporine 0.1%) ophthalmic emulsion, many patients were left wondering, 'Why is Klarity-C being discontinued?' The recall, initiated by manufacturer Imprimis NJOF, was a precautionary measure related to observed deviations in standard operating procedures.

Quick Summary

Klarity-C was recalled and discontinued in 2024 following an FDA inspection that observed manufacturing deviations. Parent company Harrow Health is transitioning patients to its FDA-approved alternative, VEVYE.

Key Points

Recall Triggered by Inspection: In May 2024, Klarity-C was voluntarily recalled by its manufacturer, Imprimis NJOF, after an FDA inspection revealed deviations from standard manufacturing procedures.
Precautionary Measure: The recall was classified as Class II, a precautionary step to address potential, though remote, risks associated with the production of a sterile ophthalmic product.
Shift to FDA-Approved Drug: Following the recall, parent company Harrow Health encouraged Klarity-C patients to transition to its FDA-approved alternative, VEVYE, via a special patient access program.
Transition Program Details: Harrow's VEVYE Access for All program allowed former Klarity-C patients to switch to VEVYE for a reduced flat rate of $59 per bottle.
Risks of Compounded Meds Highlighted: The event brought attention to the inherent differences between compounded drugs, which lack FDA approval for safety and efficacy, and rigorously regulated FDA-approved alternatives like VEVYE.
Company Consolidation: The discontinuation reflects a business strategy by Harrow Health to consolidate its market position around its FDA-approved dry eye product, providing a more reliable option for patients.

Klarity-C (cyclosporine 0.1%) was a compounded preservative-free ophthalmic emulsion used in the treatment of dry eye disease. Compounded medications are custom-made formulations prepared by a pharmacy for individual patients and, unlike mass-produced drugs, are not formally approved by the U.S. Food and Drug Administration (FDA) for safety and efficacy. In 2024, the parent company Harrow Health, through its compounding subsidiary ImprimisRx, effectively discontinued Klarity-C following a voluntary recall and subsequently shifted focus to its FDA-approved product, VEVYE.

The 2024 Voluntary Recall and FDA Observations

In May 2024, Imprimis NJOF, the manufacturer of Klarity-C, initiated a voluntary Class II recall of all unexpired lots of the ophthalmic emulsion. The recall was prompted by an FDA inspection that found deviations from standard operating procedures in the production facility. A Class II recall is issued when a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

What the FDA Found

According to the notice from the California State Board of Pharmacy, which was informed by Imprimis NJOF, the recall was taken as a precautionary measure. While all affected lots had passed standard sterility and potency tests before release, the observed deviations during the FDA inspection raised sufficient concern for the company to issue the recall out of an 'abundance of caution'. No adverse drug events were directly linked to the issue, but the potential for non-sterile conditions in an ophthalmic product—which can pose a higher risk of harm due to the eye's natural defenses being bypassed—justified the action.

Transitioning Patients to an FDA-Approved Alternative

In April 2025, Harrow, Inc., the parent company of ImprimisRx, announced a program aimed at transitioning patients who were using Klarity-C to their newly launched, FDA-approved dry eye treatment, VEVYE (cyclosporine ophthalmic solution) 0.1%. The announcement expanded Harrow’s VEVYE Access for All (VAFA) program to specifically include Klarity-C patients, offering them VEVYE for a flat rate of $59 per bottle.

This strategic move allowed Harrow to consolidate its dry eye offerings around an FDA-approved product, mitigating risks associated with compounded medications and providing a more standardized and accessible treatment option for patients. The transition program was designed to be simple, allowing patients to transfer their prescriptions easily with the help of a dedicated service.

Compounded vs. FDA-Approved Drugs

The discontinuation of Klarity-C highlights important distinctions between compounded drugs and FDA-approved pharmaceuticals. Understanding these differences can help patients and healthcare providers make informed decisions.


Feature	Klarity-C (Compounded)	VEVYE (FDA-Approved)
Regulatory Status	Not FDA-approved for safety or efficacy; custom-made per prescription.	Approved by the FDA for safety, efficacy, and quality.
Manufacturing	Produced by a compounding pharmacy with less rigorous oversight than FDA-approved facilities.	Manufactured in facilities with strict FDA-mandated quality control and testing.
Recall Risk	Higher risk of recall due to manufacturing deviations, as seen with Klarity-C.	Lower risk of recall related to manufacturing issues due to more stringent regulations.
Consistency	Batch-to-batch variations are possible due to custom preparation.	High consistency and standardization from batch to batch.
Pricing & Access	Pricing can vary; access might be limited to specific compounding pharmacies.	Pricing can be influenced by insurance or specific patient access programs like Harrow's VAFA.

A Timeline of Key Events

May 14, 2024: Imprimis NJOF voluntarily initiates a Class II recall of all unexpired lots of Klarity-C following an FDA inspection.
June 7, 2024: The FDA officially designates the action as a Class II recall.
April 10, 2025: Harrow, Inc. announces the expansion of its VEVYE Access for All program to include Klarity-C patients, facilitating a switch to the FDA-approved VEVYE.
Ongoing: The discontinuation of Klarity-C is complete, with Harrow focusing resources on its FDA-approved product pipeline and patient programs.

Conclusion

The discontinuation of Klarity-C can be traced directly to a May 2024 voluntary recall prompted by FDA observations of manufacturing irregularities at the compounding facility. While the company asserted that the health risk was unlikely, the recall demonstrated the inherent risks associated with compounded, non-FDA-approved drugs. Seizing the opportunity, parent company Harrow Health strategically shifted patients to its own FDA-approved product, VEVYE, offering a more stable and consistently regulated alternative for dry eye therapy. For patients, this event underscores the importance of staying informed about compounded medications and discussing all treatment options with their healthcare providers. For more information, the California State Board of Pharmacy posted a recall notice on its website.

Frequently Asked Questions

If you have Klarity-C drops, you should follow your healthcare provider's instructions, which likely involve discontinuing use and properly disposing of the product. The recall was issued due to manufacturing concerns, so it is not recommended to continue using it.

A compounded drug is a custom-made formulation prepared by a pharmacy and is not reviewed by the FDA for safety or efficacy. An FDA-approved drug has undergone rigorous testing and review to ensure it is safe and effective for its intended use.

No. While both contain cyclosporine 0.1% and are used for dry eye, VEVYE is an FDA-approved prescription medication, while Klarity-C was a compounded product. VEVYE offers a standardized, regulated alternative for patients.

Patients with a Klarity-C prescription can use Harrow's VEVYE Access for All program, which facilitates the transition and offers VEVYE at a flat rate of $59 per bottle.

The FDA inspection observed deviations from standard operating procedures regarding the production of Klarity-C. These concerns prompted the voluntary recall to ensure patient safety, even though initial sterility tests were passed.

The company issued the recall out of an 'abundance of caution,' stating that a health hazard was unlikely based on their assessment. However, the potential for non-sterility in an eye product necessitated the action to prevent any potential risks.

A Class II recall is a situation in which a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. It is considered less severe than a Class I recall, which involves a high risk of serious health problems or death.

You should inform your doctor about the recall and discontinuation. They can then update your records and discuss alternative treatment options, such as switching to VEVYE or other appropriate therapies.