CLASS III ONGOING Drug recall · Reported 26 Nov 2025 · FDA Enforcement Report
Klarity-C Drops (Cyclosporine) recalled by Imprimis NJOF
Imprimis Njof is recalling Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This, distributed nationwide in the US. The recall was initiated on 20 Oct 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0157-2026
- FDA event ID
- 97824
- Recalling firm
- Imprimis Njof, Ledgewood, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 20 Oct 2025
- FDA classified
- 17 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 20 Oct 2025 | Recall initiated by company | |
| 17 Nov 2025 | Classified by FDA | +28 days |
| 26 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
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
Where was it sold?
USA nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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