FDA Drugs recall ·
Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic… recall
- Recall number
- D-0157-2026
- Date
- (initiated October 20, 2025)
- Company / brand
- Imprimis NJOF, LLC
1705 Route 46 Ste 6B, Ledgewood, NJ, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 67,091 bottles
- Hazard tags
- Potency
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Subpotent Drug
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
USA nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0157-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.