Cyclosporine Recall: Klarity-C Drops 0.1%
Announced 2026-01-14 · FDA
The FDA recall covers Klarity-C Drops (Cyclosporine) 0.1%, a preservative-free sterile ophthalmic emulsion that is a compounded Rx-only product intended for office use, manufactured by Imprimis NJOF, LLC. The recall is due to subpotent drug with low severity and covers about 67,091 bottles distributed nationwide in the USA, across multiple lots with various expiration dates. The recall was initiated by the FDA and involves lots identified by the manufacturer.
| Brand | Imprimis NJOF, LLC |
|---|---|
| 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 |
| Reason | Subpotent Drug |
| Severity | low |
| Units affected | 314 |
| Distribution | USA nationwide |
| Agency | FDA |
| Recall / campaign no. | 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 |
WHAT YOU SHOULD DO
- Do not use recalled Klarity-C Drops; check your bottle's lot number against the recall list.
- Contact Imprimis NJOF, LLC for instructions on return, replacement, or disposal; provide your lot number and expiration date.
- If you have used the product and have concerns or symptoms, contact your eye care professional or pharmacist.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.