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.
What this means for you
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
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.
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