Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0157-2026·Announced 2025-11-26

Cyclosporine eye drops recalled as subpotent across many compounded lots

Imprimis NJOF is recalling 67,091 bottles of compounded Klarity-C Drops (Cyclosporine) 0.1% preservative-free ophthalmic emulsion as a subpotent drug.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the FDA designated this Class III and the record states subpotency without describing a health consequence.

Plain-English summary

Klarity-C Drops (Cyclosporine) 0.1%, a preservative-free sterile ophthalmic emulsion in 5.5 mL bottles marked office use only, compounded by Imprimis NJOF of Ledgewood, New Jersey, NDC 71384-514-05, is being recalled as a subpotent drug.

The recall covers 67,091 bottles across lots including 25JAN029 (expiring 7 November 2025), 25JAN042 (14 November 2025), 25JAN054 (21 November 2025) and 25MAR021. The product was distributed nationwide in the United States. The FDA has classified the recall as Class III, its least serious category.

The enforcement record states the subpotency without describing a health consequence, and reports no injuries.

Practices and patients holding an affected lot should follow the firm's instructions rather than stopping treatment on their own.

The recalled product

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
Manufacturer: Imprimis NJOF, LLC
Category: Drug — Ophthalmic
Hazard: subpotency
compounded
class-iii
Affected units: 67,091

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distributed nationwide across the United States.

Same manufacturer · Imprimis NJOF, LLC

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