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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Klarity-C Drops (Cyclosporine) Recalled for Being Subpotent

Agency Publication Date: November 17, 2025
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Summary

Imprimis NJOF, LLC is recalling 67,091 bottles of Klarity-C Drops (Cyclosporine 0.1%), a preservative-free sterile ophthalmic emulsion used for eye conditions. This compounded medication is being recalled because it was found to be subpotent, meaning it does not contain the full required amount of the active ingredient. The recall affects 5.5 mL bottles distributed nationwide across the United States.

Risk

Because the medication is subpotent, it may not provide the intended therapeutic effect for the patient's eye condition, potentially leading to poorly managed symptoms or a lack of improvement in the treated condition.

What You Should Do

  1. Check your medication bottle for Klarity-C Drops (Cyclosporine) 0.1% with NDC 71384-514-05.
  2. Identify if your product is affected by checking the lot number and expiration date on the packaging. Affected lots include 25JAN029 (Exp 07Nov2025), 25JAN042 (Exp 14Nov2025), 25JAN054 (Exp 21Nov2025), 25MAR021 (Exp 07Dec2025), 25APR017 (Exp 04Jan2026), 25APR025 (Exp 05Jan2026), 25MAY032 (Exp 31Jan2026), 25MAY055 (Exp 12Mar2026), 25MAY057 (Exp 14Mar2026), and 25MAY073 (Exp 21Mar2026).
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Klarity-C Drops (Cyclosporine) 0.1% (5.5 mL bottle)
Variants: Preservative-Free Sterile Ophthalmic Emulsion, Compounded Drug, Rx Only
Lot Numbers:
25JAN029 (Exp 07Nov2025)
25JAN042 (Exp 14Nov2025)
25JAN054 (Exp 21Nov2025)
25MAR021 (Exp 07Dec2025)
25APR017 (Exp 04Jan2026)
25APR025 (Exp 05Jan2026)
25MAY032 (Exp 31Jan2026)
25MAY055 (Exp 12Mar2026)
25MAY057 (Exp 14Mar2026)
25MAY073 (Exp 21Mar2026)
NDC:
71384-514-05

Office Use Only; Manufactured by Imprimis NJOF, LLC in Ledgewood, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97824
Status: Active
Manufacturer: Imprimis NJOF, LLC
Sold By: Physician offices; Medical clinics
Manufactured In: United States
Units Affected: 67,091 bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.