Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis ...

FDA Recall #D-0249-2026 — Class II — December 18, 2025

Recall #D-0249-2026 Date: December 18, 2025 Classification: Class II Status: Ongoing

Product Description

Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1

Reason for Recall

Presence of particulate matter - Glass like particles.

Recalling Firm

Imprimis NJOF, LLC — Ledgewood, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

778 boxes of 15,540 pre-filled syringes

Distribution

U.S Nationwide

Code Information

Lot: 25MAY051, Expires: 06/26/2026; 25AUG003, Expires:08/07/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated