They're prescribed to bring much needed relief, but a new report indicates they might not have delivered what was promised.
With harsh winds outdoors and dry heat indoors, winter conditions create the perfect recipe for uncomfortable, itchy dry eyes. Eye drops can help—especially if your doctor prescribes a targeted treatment to relieve irritation—but for best results, you’ll want to check your product’s labels to ensure you haven’t received a batch that is now under scrutiny for quality control issues.
On November 17, the U.S. Food and Drug Administration (FDA) updated an ongoing nationwide recall involving several lots of Klarity-C Cyclosporine 0.1% preservative-free ophthalmic drops, made by Imprimis NJOF, LLC of Ledgewood, New Jersey. The recall affects 67,091 bottles in total.
According to the newly released details, Imprimis NJOF, LLC initiated the recall after confirming that certain lots of the product were sub-potent, meaning they may not contain the full therapeutic strength that patients and clinicians expect. On November 17, the FDA updated its notice to mark the incident as a Class III event, indicating a situation in which the likelihood of adverse health consequences is low. However, sub-potent medications can still impact treatment effectiveness.
You can spot the products, distributed for “office use” in 5.5 mL bottles, using the National Drug Code (NDC) 71384-514-05. The affected eyedrops are also marked with the following lot codes and expiration dates:
- Lot 25JAN029 — Exp. Date: Nov. 07, 2025
- Lot 25JAN042 — Exp. Date: Nov. 14, 2025
- Lot 25JAN054 — Exp. Date: Nov. 21, 2025
- Lot 25MAR021 — Exp. Date: Dec. 07, 2025
- Lot 25APR017 — Exp. Date: Jan. 04, 2026
- Lot 25APR025 — Exp. Date: Jan. 05, 2026
- Lot 25MAY032 — Exp. Date: Jan. 31, 2026
- Lot 25MAY055 — Exp. Date: Mar. 12, 2026
- Lot 25MAY057 — Exp. Date: Mar. 14, 2026
- Lot 25MAY073 — Exp. Date: Mar. 21, 2026
The affected drops were distributed across the U.S. by prescription only, spanning multiple lots with expiration dates ranging from November 2025 through March 2026. No public press release has been issued, but the company sent notifications to consignees by letter to inform them of the oversight.
Cyclosporine is an immunosuppressant medication commonly used for managing chronic eye-surface inflammation, increasing tear production, and easing symptoms such as dryness, redness, and irritation. According to the Mayo Clinic, it is also used to treat the allergic eye condition vernal keratoconjunctivitis.
The National Library of Medicine explains that ophthalmic cyclosporine can be formulated “as a solution (liquid) and as an emulsion (combination of two unmixable liquids) to instill in the eye.” The affected drops were categorized in the FDA’s report as “Sterile Ophthalmic Emulsion,” meaning their compounded ingredients are not fully dissolved.
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