Klarity-C Cyclosporine Ophthalmic Drops Recalled for Subpotency

Key Clinical Summary

• Imprimis NJOF, LLC voluntarily recalled Klarity-C drops (cyclosporine) 0.1% due to subpotency, impacting 67 091 bottles distributed nationwide.
• The recall, classified as Class III, was initiated on October 20, 2025, with affected lots expiring between November 2025 to March 2026.
• Klarity-C drops are used to increase tear production in patients with dry eye disease (keratoconjunctivitis sicca); subpotency may lessen therapeutic effectiveness.

Imprimis NJOF, LLC has issued a voluntary nationwide recall of its compounded ophthalmic product Klarity-C drops (cyclosporine) 0.1%, a preservative-free sterile emulsion formulated for office use. The recall affects 67 091 bottles of the drug, packaged in 5.5 mL bottles and labeled for prescription use only. The affected lots include 25JAN029 through 25MAY073, with expiration dates ranging from November 2025 to March 2026. The recall, identified as D-0157-2026, is categorized under Class III, meaning use or exposure is not likely to cause adverse health consequences.

The recall was initiated voluntarily by Imprimis NJOF, LLC on October 20, 2025, following the discovery that certain batches of Klarity-C drops were subpotent, failing to meet the required strength specifications for cyclosporine. The company notified its customers by letter, and as of the latest US Food and Drug Administration (FDA) Enforcement Report update on November 17, 2025. The recall remains ongoing. No press release was issued for this event. The affected product was distributed nationwide across the US to health care providers for in-office use.

Klarity-C drops (cyclosporine) are typically prescribed to increase tear production in patients with keratoconjunctivitis sicca, commonly known as dry eye disease, where tear production is presumed to be suppressed due to ocular inflammation. Subpotent formulations may reduce the therapeutic efficacy of treatment, potentially leading to inadequate symptom relief for patients relying on the drug to manage chronic ocular surface inflammation and dryness.