October 2025 FDA Recall Drug by Imprimis Njof, Llc
D-0157-2026 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Imprimis Njof, Llc on October 20, 2025 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0157-2026

Reason for Recall
Subpotent Drug
Initiated
10-20-2025
Reported
11-26-2025
Quantity
67,091 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
97824
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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