D-0835-2026 Class III Ongoing

Recalled by ImprimisRx NJ LLC — Ledgewood, NJ

FDA drug recall D-0835-2026 was initiated by ImprimisRx NJ LLC on August 24, 2026 and is designated Class III. Reason for recall: Subpotent Drug The recall status is ongoing. Affected quantity: 772 bottles.

Recall Details

Product Type
Drugs
Report Date
September 16, 2026
Initiation Date
August 24, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
772 bottles

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

Reason for Recall

Subpotent Drug

Distribution Pattern

USA Nationwide

Code Information

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