Class II · Moderate risk
Klarity-C (cyclosporine)
Lack of Assurance of Sterility
Klarity-C Drops
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West, Ledgewood, NJ 07852, NDC 71384-514-05
Affected NDC
71384-0514-05
Compare with the code on your package — it is the most precise check available.
Drug: Cyclosporine Category: Eye Drops & Ophthalmic
- Recalling firm
- Imprimis NJOF, LLC
- NDC code
- 71384-514-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0157-2026 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Cyclosporine recalls
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Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent: Out of Specification result observed for low assay
Class II · Moderate risk
Cyclosporine
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Other recalls by Imprimis NJOF, LLC
All 2025 recalls
Class II · Moderate risk
Tri-Moxi+¿
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin Ketorolac
Presence of particulate matter - Glass like particles.
Class II · Moderate risk
Dexamethasone Moxifloxacin
Presence of particulate matter - Glass like particles.
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
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