Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprim
Summary
The FDA issued a Class III for Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dro by ImprimisRx NJ LLC. Reason: Subpotent Drug.
Details
Source
Drug Recall
External ID
D-0835-2026
Action Date
2026-09-16
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: 26JAN035, BUD 09/07/2026; 26FEB015, BUD 09/24/2026
Quantity Affected: 772 bottles
Reason for Recall
Subpotent Drug
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-24
Company
Ledgewood, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 40 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ImprimisRx NJ LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ImprimisRx NJ LLC have FDA actions?
This is the only FDA action we have on record for ImprimisRx NJ LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0835-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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