Lower risk Drug recall · FDA · Published October 20, 2025

Klarity-C Drops Recall: Subpotent Drug Risk

Imprimis NJOF recalls specific lots of Klarity-C Cyclosporine eye drops due to subpotent drug levels. This compounded medication requires immediate action for safety.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0157-2026Drug Imprimis NJOF ›

Lower-risk recall

Subpotent Drug

Take action

Contact the company

Recalling firmImprimis NJOF, LLC1705 Route 46 Ste 6B · Ledgewood, NJ 07852-9720

✎ GovInfoNow plain-language explainer

Imprimis NJOF is recalling specific lots of Klarity-C Cyclosporine eye drops (0.1% preservative-free) because they may contain lower-than-stated drug levels. This could lead to ineffective treatment for patients needing immunosuppression. Read more at govinfonow.com/recall/31687-klarity-c-drops-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/31687-klarity-c-drops-recall-subpotent-drug-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0157-2026

Cite this page

“Klarity-C Drops Recall: Subpotent Drug Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31687-klarity-c-drops-recall-subpotent-drug-risk. Based on FDA recall #D-0157-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0157-2026%22&limit=1).

The FDA announced on Oct. 20, 2025, that Imprimis NJOF, LLC is recalling Klarity-C Drops due to subpotent drug risks. The voluntary Class III recall affects 67,091 bottles distributed nationwide.

How to tell if you have it

Brand: Imprimis NJOF
Product: Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion
NDC: 71384-514-05
Lot codes: 25JAN029, 25JAN042, 25JAN054, 25MAR021, 25APR017, 25APR025, 25MAY032, 25MAY055, 25MAY057, 25MAY073
Expiration dates: 07Nov2025 through 21Mar2026
Size: 5.5 mL bottle

The hazard

The recall is classified as a Class III hazard due to the drug being subpotent, meaning it does not meet the required strength specifications.

Context

GovInfoNow's records show Imprimis NJOF, LLC has 13 other recalls on record since Dec. 17, 2020. Recent brand recalls include an Imprimis Tri-Moxi+ Intraocular Injection recall for glass particles risk on Dec. 18, 2025, and an Imprimis Epinephrine Vials recall for subpotent drug risk on July 9, 2025. Other recent recalls of similar products include an ImprimisRx Povidone Iodine Ophthalmic Solution recall for subpotent drug risk (Aug. 24, 2026) and K.C. Pharmaceuticals Sterile Eye Drops AC recall for lack of sterility risk (March 3, 2026).

How to tell if you have this one

Check the product label for the lot numbers listed: 25JAN029, 25JAN042, 25JAN054, 25MAR021, 25APR017, 25APR025, 25MAY032, 25MAY055, 25MAY057, 25MAY073. These lots were manufactured by Imprimis NJOF, LLC and sold with specific expiration dates.

Brand
Imprimis NJOF
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the lot numbers listed in the recall: 25JAN029, 25JAN042, 25JAN054, 25MAR021, 25APR017, 25APR025, 25MAY032, 25MAY055, 25MAY057, 25MAY073.
Contact Doctor
Discuss alternative treatment options with your healthcare provider if you have the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 37 days after the firm started it.

Oct 20, 2025Firm started the recall
Nov 17, 2025FDA classified it Class III
Nov 26, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Are there any safety risks from using this product?

The recall is for potential treatment ineffectiveness, not immediate safety risks like injury or death. This is a low-risk situation.

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Link to this recall

<a href="https://govinfonow.com/recall/31687-klarity-c-drops-recall-subpotent-drug-risk">Klarity-C Drops Recall: Subpotent Drug Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0157-2026 (October 20, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0157-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.