Imprimis NJOF, LLC: Drug Recall

Recall #D-0250-2026 · 12/18/2025

Class II: Risk

Recall Details

Recall Number: D-0250-2026
Classification: Class II
Product Type: Drug
Recalling Firm: Imprimis NJOF, LLC
Status: Ongoing
Date Initiated: 12/18/2025
Location: Ledgewood, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 596 boxes of 11,920 pre-filled syringes

Reason for Recall

Presence of particulate matter - Glass like particles.

Product Description

Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-513-01.

Distribution Pattern

U.S Nationwide

Other Recalls by Imprimis NJOF, LLC

Class II: Risk 12/18/2025

Presence of particulate matter - Glass like particles.
Class II: Risk 12/18/2025

Presence of particulate matter - Glass like particles.
Class III: Low Risk 10/20/2025

Subpotent Drug
Class III: Low Risk 07/09/2025

Sub-Potent Drug: Subpotent assay results during stability testing.
Class II: Risk 07/09/2025

Sub-Potent Drug: Subpotent assay results during stability testing.

View all recalls by Imprimis NJOF, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.