RecallReported September 16, 2026

Class III recall by ImprimisRx NJ LLC

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 R…

FDA's record ↗

FDA's enforcement report of September 16, 2026 lists a Class III recall by ImprimisRx NJ LLC of Ledgewood, NJ. Product: Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 R…. Status: Ongoing.

On the record

Recalling firm
ImprimisRx NJ LLC
Location
Ledgewood, NJ
Classification
Class III
Status
Ongoing
Recall number
D-0835-2026
Product type
Drugs
Recall initiated
2026-08-24
Reported by FDA
2026-09-16
Source
FDA enforcement reports ↗

The full record

An account shows the reason for the recall, where the product was distributed and the lots.

What a recall is

FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.

More

Watch ImprimisRx NJ LLC

A free account shows the last 7 days of every record. Pro adds a watchlist: one email when FDA acts on a company you name.

From FDA enforcement reports. The record may have changed since it was read.

Approve Suite is not affiliated with FDA, or with ImprimisRx NJ LLC.

See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.