Klarity-C Drops (Cyclosporine) 0.1% recall
FDA recall D-0157-2026 · initiated Oct 20, 2025
Imprimis NJOF, LLC recalled Klarity-C Drops (Cyclosporine) 0.1% in Oct 2025 — an FDA Class III recall (D-0157-2026) because Subpotent Drug.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent Drug
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 67,091 bottles
Details
- Product
- 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
- Recalling company
- Imprimis NJOF, LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide
- Initiated
- Oct 20, 2025
- FDA report date
- Nov 26, 2025
Frequently asked
- Was Klarity-C Drops (Cyclosporine) 0.1% recalled?
- Imprimis NJOF, LLC recalled Klarity-C Drops (Cyclosporine) 0.1% in Oct 2025 — an FDA Class III recall (D-0157-2026) because Subpotent Drug. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Klarity-C Drops (Cyclosporine) 0.1% recalled?
- Per the FDA enforcement record, the reason for recall D-0157-2026 was: Subpotent Drug
- Is a recalled Klarity-C Drops (Cyclosporine) 0.1% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Klarity-C Drops (Cyclosporine) 0.1% are affected?
- Distributed: USA nationwide. The recall covers these lots — Lot #:25JAN029, exp. date 07Nov2025; 25JAN042, exp. date 14Nov2025; 25JAN054, exp. date 21Nov2025; 25MAR021, exp. date 07Dec2025; 25APR017, exp. date 04Jan2026, 25APR025, exp. date 05Jan2026; 25MAY032, exp. date 31Jan2026; 25MAY055, exp. date 12Mar2026; 25MAY057, exp. date 14Mar2026; 25MAY073, exp. date 21Mar2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0157-2026.