FDA Drugs recall ·

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution… recall

Recall number
D-0835-2026
Date
(initiated August 24, 2026)
Company / brand
ImprimisRx NJ LLC
1705 Us Highway 46 Ste 4, Ledgewood, NJ, United States
Category
Drugs › Class III
Classification
Class III
Status
Ongoing
Units affected
772 bottles
Hazard tags
Potency
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10

Why was it recalled?

Subpotent Drug

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026

Distribution

USA Nationwide

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (drugs), recall D-0835-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.